Family of Steam sterilizers B17 B22 Series

K161848 · Cefla S.C. · FLE · Feb 23, 2017 · General Hospital

Device Facts

• Record ID: K161848
• Device Name: Family of Steam sterilizers B17 B22 Series
• Applicant: Cefla S.C.
• Product Code: FLE · General Hospital
• Decision Date: Feb 23, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6880
• Device Class: Class 2

Intended Use

B CLASSIC-17 is a steam sterilizer that is intended for use by a heath care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process. The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.

Device Story

Table-top steam sterilizers (B17/B22 series) for healthcare facilities; use saturated steam at high pressure/temperature to sterilize re-usable medical instruments. Input: demineralized water; process: fractionated vacuum system removes air from hollow/porous materials; electric heating elements maintain chamber temperature. Output: sterilized instruments; cycle reports (PDF/USB/Ethernet/Wi-Fi). Operated by healthcare staff; output used to confirm sterilization success via cycle outcome (positive/negative) and process parameters (temp/pressure/time). Benefits: ensures sterility of re-usable medical devices, including dental handpieces and porous textiles.

Clinical Evidence

Bench testing only. Validated per AAMI ST55:2010. Biological indicators achieved SAL 10^-6. Chamber temperature verified within -0°C to +3°C of set point. Bowie-Dick test pack showed uniform color change. Air leak rate < 1mmHg. Moisture retention < 0.5% for wrapped instruments and < 2% for textiles.

Technological Characteristics

Table-top steam sterilizer; 304/316L stainless steel chamber; fractionated vacuum system; electric heating foil; 17L or 22L volume; connectivity via Ethernet/Wi-Fi/USB; sterilization temps 121°C/134°C; pressure 1.1/2.1 bar; air filtration 0.027 μm (99.999% efficiency).

Indications for Use

Indicated for use by healthcare providers (hospitals, medical/dental practices, clinics, nursing homes) to sterilize heat/moisture-resistant, steam-compatible re-usable medical products. Contraindicated for fluids, liquids, or pharmaceutical products.

Regulatory Classification

Identification

A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.

Predicate Devices

• Family of steam sterilizers B28 series (K151597)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines extending from the bottom profile. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 23, 2017

Cefla S.C. c/o Maurizio Pantaleoni ISEMED srl Via Altobelli Bonetti 3/A Imola, Bologna 40026 ITALY

Re: K161848

Trade/Device Name: Family of Steam Sterilizers B17 B22 Series Regulation Number: 21 CFR 880.6880 Regulation Name: Steam sterilizer Regulatory Class: Class II Product Code: FLE Dated: January 15, 2017 Received: January 18, 2017

Dear Maurizio Pantaleoni:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K161848

Device Name Family of Steam sterilizers B17 B22 series

Indications for Use (Describe)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

B CLASSIC-17 is a steam sterilizer that is intended for use by a heath care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process.

The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.

Program description, cycle times, temperature and dry time are described in the table below:

{3}------------------------------------------------

### B CLASSIC-17 model

| MODEL NAME | CYCLE NAME | STERILIZATION<br>TEMPERATURE /<br>EXPOSURE TIME | DRYING<br>TIME (*) | DESCRIPTION OF MAXIMUM LOAD AND TYPE<br>(**) (***) |
|--------------|---------------------------------------------------------------------------|-------------------------------------------------|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B Classic-17 | (C1)<br>UNIVERSAL<br>134<br>(3 prevacuum<br>steps; -0.8 bar<br>each step) | 134°C / 273°F<br>4 minutes | 12.75 min | 4 kg unwrapped metal or polymer instruments and<br>dental handpieces (max 1.33 kg per tray)<br>2 kg single package metal or polymer instruments<br>and dental handpieces (max 1.33 kg per tray)<br>1kg double package metal or polymer instruments<br>and dental handpieces (max 1.33 kg per tray)<br>0.6 kg unwrapped porous and fabric textiles<br>0.5 kg single package porous and fabric textiles<br>0.4 kg double package porous and fabric textiles |
| | (C2)<br>UNIVERSAL<br>121<br>(3 prevacuum<br>steps; -0.8 bar<br>each step) | 121°C / 250°F<br>20 minutes | 12.75 min | 4 kg unwrapped metal or polymer instruments and<br>dental handpieces (max 1.33 kg per tray)<br>2 kg single package metal or polymer instruments<br>and dental handpieces (max 1.33 kg per tray)<br>1kg double package metal or polymer instruments<br>and dental handpieces (max 1.33 kg kg per tray)<br>0.6 kg unwrapped porous and fabric textiles<br>0.5 kg single package porous and fabric textiles<br>0.4 kg double package porous and fabric textiles |
| | (C4) SOLID 134<br>(1 prevacuum<br>step; -0.8 bar) | 134°C / 273°F<br>4 minutes | 12.75 min | 4 kg unwrapped metal or polymer instruments<br>(max 1.33 kg per tray)<br>2 kg single package metal or polymer instruments<br>(max 1.33 kg per tray) |
| | (C5) HOLLOW<br>134<br>(3 prevacuum<br>steps; -0.8 bar<br>each step) | 134°C / 273°F<br>4 minutes | 3 min | 4 kg unwrapped metal or polymer instruments and<br>dental handpieces (max 1.33 kg per tray) |
| | HELIX/BD<br>TEST<br>(3 prevacuum<br>steps; -0.8 bar<br>each step) | 134°C / 273°F<br>35 minutes | 1.5 min | Test device only (without another load) |
| | VACUUM TEST<br>(-0.8 bar) | / | / | Empty chamber<br>Vacuum -0.8 bar<br>Test Time: 27 min |
| | VACUUM +<br>HELIX/BD<br>TEST (****) | / | / | / |

B CLASSIC-17 Factory programmed sterilization cycles and parameters

(*) Default drying time, but the drying time can be manually increased

(**) Cycles C1, C2 are validated to sterilize up to 6 single sided lumened devices with inner diameter/length of the lumen: ≥1.25 mm/≤118 mm (corresponding to "hollow A" cavities with a length/diameter (L/D) ratio = 1 ≤ L/D ≤ 750).

Cycles C4 and C5 are validated to sterilize up to 6 double sided lumened devices with inner diameter/length of the lumen: ≥10 mm / ≤115 mm

(***) If the material is sterilized "unwrapped" the sterilized material shall used immediately after sterilization (the cycle shall be considered as immediate use cycle)

(****) This program enables to execute, in sequence, Vacuum test and Helix/BD test (nevertheless each test is executed separately)

{4}------------------------------------------------

Type of Use (Select one or both, as applicable)

__ Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{5}------------------------------------------------

# Indications for Use

510(k) Number (if known) K161848

Device Name Family of Steam sterilizers B17 B22 series

Indications for Use (Describe)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

B CLASSIC-22 is a steam sterilizer that is intended for use by a heath care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process.

The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.

Program description, cycle times, temperature and dry time are described in the table below:

{6}------------------------------------------------

### B CLASSIC-22 model

| | | | Chamber Dimensions (Depth 450mm / Diameter 250mm / Volume about 22 liters) | |
|--|--|--|----------------------------------------------------------------------------|--|
|--|--|--|----------------------------------------------------------------------------|--|

| MODEL NAME | CYCLE<br>NAME | STERILIZATION<br>TEMPERATURE /<br>EXPOSURE TIME | DRYING<br>TIME (*) | DESCRIPTION OF MAXIMUM LOAD AND TYPE<br>(**) (***) |
|--------------|---------------------------------------------------------------------------|-------------------------------------------------|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B Classic-22 | (C1)<br>UNIVERSAL<br>134<br>(3 prevacuum<br>steps; -0.8 bar<br>each step) | 134°C / 273°F<br>4 minutes | 14.5 min | 4.5 kg unwrapped metal or polymer instruments and<br>dental handpieces (max 1.33 kg per tray)<br>2.25 kg single package metal or polymer instruments<br>and dental handpieces (max 1.33 kg per tray)<br>1.25 kg double package metal or polymer instruments<br>and dental handpieces (max 1.33 kg per tray)<br>0.75 kg unwrapped porous and fabric textiles<br>0.60 kg single package porous and fabric textiles<br>0.50 kg double package porous and fabric textiles |
| | (C2)<br>UNIVERSAL<br>121<br>(3 prevacuum<br>steps; -0.8 bar<br>each step) | 121°C / 250°F<br>20 minutes | 14.5 min | 4.5 kg unwrapped metal or polymer instruments and<br>dental handpieces (max 1.33 kg per tray)<br>2.25 kg single package metal or polymer instruments<br>and dental handpieces (max 1.33 kg per tray)<br>1.25 kg double package metal or polymer instruments<br>and dental handpieces (max 1.33 kg per tray)<br>0.75 kg unwrapped porous and fabric textiles<br>0.60 kg single package porous and fabric textiles<br>0.50 kg double package porous and fabric textiles |
| | (C4) SOLID<br>134<br>(1 prevacuum<br>step; -0.8 bar) | 134°C / 273°F<br>4 minutes | 14.5 min | 4.50 kg unwrapped metal or polymer instruments<br>(max 1.33 kg per tray)<br>2.25 kg single package metal or polymer instruments<br>(max 1.33 kg per tray) |
| | (C5)<br>HOLLOW 134<br>(3 prevacuum<br>steps; -0.8 bar<br>each step) | 134°C / 273°F<br>4 minutes | 3 min | 4.50 kg unwrapped metal or polymer instruments and<br>dental handpieces (max 1.33 kg per tray) |
| | HELIX/BD<br>TEST<br>(3 prevacuum<br>steps; -0.8 bar<br>each step) | 134°C / 273°F<br>3.5 minutes | 1.5 min | Test device only (without another load) |
| | VACUUM<br>TEST<br>(-0.8 bar) | / | / | Empty chamber<br>Vacuum -0.8 bar<br>Test Time: 27 min |
| | VACUUM +<br>HELIX/BD<br>TEST (****) | / | / | / |

B CLASSIC-22 Factory programmed sterilization cycles and parameters

(*) Default drying time, but the drying time can be manually increased

(**) Cycles C1, C2 are validated to sterilize up to 6 single sided lumened devices with inner diameter/length of the lumen: ≥1.25 mm/≤118 mm (corresponding to "hollow A" cavities with a length/diameter (L/D) ratio = 1 ≤ L/D ≤ 750).

Cycles C4 and C5 are validated to sterilize up to 6 double sided lumened devices with inner diameter/length of the lumen: ≥10 mm / ≤115 mm

(***) If the material is sterilized "unwrapped" the sterilized material shall used immediately after sterilization (the cycle shall be considered as immediate use cycle)

(****) This program enables to execute, in sequence, Vacuum test and Helix/BD test (nevertheless each test is executed separately)

{7}------------------------------------------------

Type of Use (Select one or both, as applicable)

__ Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{8}------------------------------------------------

# Indications for Use

510(k) Number (if known) K161848

Device Name Family of Steam sterilizers B17 B22 series

Indications for Use (Describe)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

B FUTURA-17 is a steam sterilizer that is intended for use by a heath care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process.

The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.

Program description, cycle times, temperature and dry time are described in the table below:

{9}------------------------------------------------

### B FUTURA-17 model

Chamber Dimensions (Depth 350mm / Diameter 250mm / Volume about 17 liters)

| MODEL NAME | CYCLE<br>NAME | STERILIZATION<br>TEMPERATURE /<br>EXPOSURE TIME | DRYING<br>TIME (*) | DESCRIPTION OF MAXIMUM LOAD AND TYPE<br>(**) (***) |
|-------------|---------------------------------------------------------------------------|-------------------------------------------------|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B Futura-17 | (C1)<br>UNIVERSAL<br>134<br>(3 prevacuum<br>steps; -0.8 bar<br>each step) | 134°C / 273°F<br>4 minutes | 9.67 min | 4 kg unwrapped metal or polymer instruments and<br>dental handpieces (max 1.33 kg per tray)<br>2 kg single package metal or polymer instruments<br>and dental handpieces (max 1.33 kg per tray)<br>1kg double package metal or polymer instruments<br>and dental handpieces (max 1.33 kg per tray)<br>0.6 kg unwrapped porous and fabric textiles<br>0.5 kg single package porous and fabric textiles<br>0.4 kg double package porous and fabric textiles |
| | (C2)<br>UNIVERSAL<br>121<br>(3 prevacuum<br>steps: -0.8 bar<br>each step) | 121°C / 250°F<br>20 minutes | 9.67 min | 4 kg unwrapped metal or polymer instruments and<br>dental handpieces (max 1.33 kg per tray)<br>2 kg single package metal or polymer instruments<br>and dental handpieces (max 1.33 kg per tray)<br>1kg double package metal or polymer instruments<br>and dental handpieces (max 1.33 kg per tray)<br>0.6 kg unwrapped porous and fabric textiles<br>0.5 kg single package porous and fabric textiles<br>0.4 kg double package porous and fabric textiles |
| | (C4) SOLID<br>134<br>(1 prevacuum<br>step; -0.8 bar) | 134°C / 273°F<br>4 minutes | 9.67 min | 4 kg unwrapped metal or polymer instruments<br>(max 1.33 kg per tray)<br>2 kg single package metal or polymer instruments<br>(max 1.33 kg per tray) |
| | (C5)<br>HOLLOW 134<br>(3 prevacuum<br>steps: -0.8 bar<br>each step) | 134°C / 273°F<br>4 minutes | 3 min | 4 kg unwrapped metal or polymer instruments and<br>dental handpieces (max 1.33 kg per tray) |
| | HELIX/BD<br>TEST<br>(3 prevacuum<br>steps: -0.8 bar<br>each step) | 134°C / 273°F<br>3.5 minutes | 1.33 min | Test device only (without another load) |
| | VACUUM<br>TEST<br>(-0.8 bar) | / | / | Empty chamber<br>Vacuum -0.8 bar<br>Test Time: 27 min |
| | VACUUM +<br>HELIX/BD<br>TEST (****) | / | / | |

B FUTURA-17 Factory programmed sterilization cycles and parameters

(*) Default drying time, but the drying time can be manually increased

(**) Cycles C1, C2 are validated to sterilize up to 6 single sided lumened devices with inner diameter/length of the lumen: ≥1.25 mm/≤118 mm (corresponding to "hollow A" cavities with a length/diameter (L/D) ratio = 1 ≤ L/D ≤ 750).

Cycles C4 and C5 are validated to sterilize up to 6 double sided lumened devices with inner diameter/length of the lumen: ≥10 mm / ≤115 mm

(***) If the material is sterilized "unwrapped" the sterilized material shall used immediately after sterilization (the cycle shall be considered as immediate use cycle)

(****) This program enables to execute, in sequence, Vacuum test and Helix/BD test (nevertheless each test is executed separately)

{10}------------------------------------------------

Type of Use (Select one or both, as applicable)

__ Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{11}------------------------------------------------

# Indications for Use

510(k) Number (if known) K161848

Device Name Family of Steam sterilizers B17 B22 series

Indications for Use (Describe)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

B FUTURA-22 is a steam sterilizer that is intended for use by a heath care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process.

The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.

Program description, cycle times, temperature and dry time are described in the table below:

{12}------------------------------------------------

# B FUTURA-22 model

Chamber Dimensions (Depth 450mm / Diameter 250mm / Volume about 22 liters)

| MODEL NAME | CYCLE<br>NAME | STERILIZATION<br>TEMPERATURE /<br>EXPOSURE TIME | DRYING<br>TIME (*) | DESCRIPTION OF MAXIMUM LOAD AND TYPE<br>(**) (***) |
|-------------|---------------------------------------------------------------------------|-------------------------------------------------|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B Futura-22 | (C1)<br>UNIVERSAL<br>134<br>(3 prevacuum<br>steps; -0.8 bar<br>each step) | 134°C / 273°F<br>4 minutes | 11.5 min | 4.5 kg unwrapped metal or polymer instruments and<br>dental handpieces (max 1.33 kg per tray)<br>2.25 kg single package metal or polymer instruments<br>and dental handpieces (max 1.33 kg per tray)<br>1.25 kg double package metal or polymer instruments<br>and dental handpieces (max 1.33 kg per tray)<br>0.75 kg unwrapped porous and fabric textiles<br>0.60 kg single package porous and fabric textiles<br>0.50 kg double package porous and fabric textiles |
| | (C2)<br>UNIVERSAL<br>121<br>(3 prevacuum<br>steps: -0.8 bar<br>each step) | 121°C / 250°F<br>20 minutes | 11.5 min | 4.5 kg unwrapped metal or polymer instruments and<br>dental handpieces (max 1.33 kg per tray)<br>2.25 kg single package metal or polymer instruments<br>and dental handpieces (max 1.33 kg per tray)<br>1.25 kg double package metal or polymer instruments<br>and dental handpieces (max 1.33 kg per tray)<br>0.75 kg unwrapped porous and fabric textiles<br>0.60 kg single package porous and fabric textiles<br>0.50 kg double package porous and fabric textiles |
| | (C4) SOLID<br>134<br>(1 prevacuum<br>step; -0.8 bar) | 134°C / 273°F<br>4 minutes | 11.5 min | 4.50 kg unwrapped metal or polymer instruments<br>(max 1.33 kg per tray)<br>2.25 kg single package metal or polymer instruments<br>(max 1.33 kg per tray) |
| | (C5)<br>HOLLOW 134<br>(3 prevacuum<br>steps; -0.8 bar<br>each step) | 134°C / 273°F<br>4 minutes | 3 min | 4.50 kg unwrapped metal or polymer instruments and<br>dental handpieces (max 1.33 kg per tray) |
| | HELIX/BD<br>TEST<br>(3 prevacuum<br>steps; -0.8 bar<br>each step) | 134°C / 273°F<br>3.5 minutes | 1.33 min | Test device only (without another load) |
| | VACUUM<br>TEST<br>(-0.8 bar) | / | / | Empty chamber<br>Vacuum -0.8 bar<br>Test Time: 27 min |
| | VACUUM +<br>HELIX/BD<br>TEST | / | / | / |

B FUTURA-22 Factory programmed sterilization cycles and parameters

(*) Default drying time, but the drying time can be manually increased

(**) Cycles C1, C2 are validated to sterilize up to 6 single sided lumened devices with inner diameter/length of the lumen: ≥1.25 mm/≤118 mm (corresponding to "hollow A" cavities with a length/diameter (L/D) ratio = 1 ≤ L/D ≤ 750).

Cycles C4 and C5 are validated to sterilize up to 6 double sided lumened devices with inner diameter/length of the lumen: ≥10 mm / ≤115 mm

(***) If the material is sterilized "unwrapped" the sterilized material shall used immediately after sterilization (the cycle shall be considered as immediate use cycle)

(****) This program enables to execute, in sequence, Vacuum test and Helix/BD test (nevertheless each test is executed separately)

{13}------------------------------------------------

Type of Use (Select one or both, as applicable)

__ Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{14}------------------------------------------------

# 510(k) Summary

### Family of Steam sterilizers B17 B22 series

## K161848

#### 2.1. General Information

Submitter:

CEFLA S.C. Via Selice Provinciale, 23/A 40026 - IMOLA (BO) ITALY

Establishment Registration Number: 3006610845

| Contact Person in Italy: | Maurizio Pantaleoni<br>ISEMED srl<br>Via Altobelli Bonetti 3/a<br>40026 Imola (BO)<br>Italy<br>Mob.phone: [phone]<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary Preparation Date: | February 15, 2017 |

2.2. Names

| Device Name: | Family of Steam sterilizer B17 B22 series |
|----------------------|-------------------------------------------|
| Classification Name: | Steam Sterilizer |
| Product Code: | FLE |
| Regulation number: | 880.6880 |
| Class: | II |

#### Predicate Devices 2.3.

The Family of steam sterilizers B17 B22 series is substantially equivalent to the following legally marketed predicate device:

| Applicant | Carlos Concession Comers of Concession Comers of Concession Comers of Concession Comers of Concession Comers of Concession Comers of Concession Comers of Concession Comers of<br>Device name | 510(k) Number |
|------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| CEFLA S.C. | Family of steam sterilizers B28 series | K151597 |

{15}------------------------------------------------

#### 2.4. Indications for Use

B CLASSIC-17 is a steam sterilizer that is intended for use by a health care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process.

The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.

#### B CLASSIC-17 model

Chamber Dimensions (Depth 350mm / Diameter 250mm / Volume about 17 liters)

| MODEL NAME | CYCLE NAME | STERILIZATION<br>TEMPERATURE /<br>EXPOSURE TIME | DRYING<br>TIME (*) | DESCRIPTION OF MAXIMUM LOAD AND TYPE<br>(**) (***) |
|--------------|---------------------------------------------------------------------------|-------------------------------------------------|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B Classic-17 | (C1)<br>UNIVERSAL<br>134<br>(3 prevacuum<br>steps; -0.8 bar<br>each step) | 134°C / 273°F<br>4 minutes | 12.75 min | 4 kg unwrapped metal or polymer instruments and<br>dental handpieces (max 1.33 kg per tray)<br>2 kg single package metal or polymer instruments<br>and dental handpieces (max 1.33 kg per tray)<br>1kg double package metal or polymer instruments<br>and dental handpieces (max 1.33 kg per tray)<br>0.6 kg unwrapped porous and fabric textiles<br>0.5 kg single package porous and fabric textiles<br>0.4 kg double package porous and fabric textiles |
| | (C2)<br>UNIVERSAL<br>121<br>(3 prevacuum<br>steps; -0.8 bar<br>each step) | 121°C / 250°F<br>20 minutes | 12.75 min | 4 kg unwrapped metal or polymer instruments and<br>dental handpieces (max 1.33 kg per tray)<br>2 kg single package metal or polymer instruments<br>and dental handpieces (max 1.33 kg per tray)<br>1kg double package metal or polymer instruments<br>and dental handpieces (max 1.33 kg per tray)<br>0.6 kg unwrapped porous and fabric textiles<br>0.5 kg single package porous and fabric textiles<br>0.4 kg double package porous and fabric textiles |
| | (C4) SOLID 134<br>(1 prevacuum<br>step; -0.8 bar) | 134°C / 273°F<br>4 minutes | 12.75 min | 4 kg unwrapped metal or polymer instruments<br>(max 1.33 kg per tray)<br>2 kg single package metal or polymer instruments<br>(max 1.33 kg per tray) |
| | (C5) HOLLOW<br>134<br>(3 prevacuum<br>steps; -0.8 bar<br>each step) | 134°C / 273°F<br>4 minutes | 3 min | 4 kg unwrapped metal or polymer instruments and<br>dental handpieces (max 1.33 kg per tray) |
| | HELIX/BD<br>TEST<br>(3 prevacuum<br>steps; -0.8 bar<br>each step) | 134°C / 273°F<br>3.5 minutes | 1.5 min | Test device only (without another load) |
| | VACUUM TEST<br>(-0.8 bar) | / | / | Empty chamber<br>Vacuum -0.8 bar<br>Test Time: 27 min |
| | VACUUM +<br>HELIX/BD<br>TEST | / | / | / |

Table 1 - B CLASSIC-17 Factory programmed sterilization cycles and parameters

(*) Default drying time, but the drying time can be manually increased

{16}------------------------------------------------

(**) Cycles C1, C2 are validated to sterilize up to 6 single sided lumened devices with inner diameter/length of the lumen: ≥1.25 mm/≤118 mm (corresponding to "hollow A" cavities with a length/diameter (L/D) ratio = 1 ≤ L/D ≤ 750).

Cycles C4 and C5 are validated to sterilize up to 6 double sided lumened devices with inner diameter/length of the lumen: ≥10 mm / ≤115 mm

(***) If the material is sterilized "unwrapped" the sterilized material shall used immediately after sterilization (the cycle shall be considered as immediate use cycle)

(***) This program enables to execute, in sequence, Vacuum test and Helix/BD test (nevertheless each test is executed separately)

B CLASSIC-22 is a steam sterilizer that is intended for use by a health care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process.

The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.

## B CLASSIC-22 model

Chamber Dimensions (Depth 450mm / Diameter 250mm / Volume about 22 liters)

| MODEL NAME | CYCLE<br>NAME | STERILIZATION<br>TEMPERATURE /<br>EXPOSURE TIME | DRYING<br>TIME (*) | DESCRIPTION OF MAXIMUM LOAD AND TYPE<br>(**) (***) |
|--------------|---------------------------------------------------------------------------|-------------------------------------------------|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (C1)<br>UNIVERSAL<br>134<br>(3 prevacuum<br>steps; -0.8 bar<br>each step) | 134°C / 273°F<br>4 minutes | 14.5 min | 4.5 kg unwrapped metal or polymer instruments and<br>dental handpieces (max 1.33 kg per tray)<br>2.25 kg single package metal or polymer instruments<br>and dental handpieces (max 1.33 kg per tray)<br>1.25 kg double package metal or polymer instruments<br>and dental handpieces (max 1.33 kg per tray)<br>0.75 kg unwrapped porous and fabric textiles<br>0.60 kg single package porous and fabric textiles<br>0.50 kg double package porous and fabric textiles |
| B Classic-22 | (C2)<br>UNIVERSAL<br>121<br>(3 prevacuum<br>steps; -0.8 bar<br>each step) | 121°C / 250°F<br>20 minutes | 14.5 min | 4.5 kg unwrapped metal or polymer instruments and<br>dental handpieces (max 1.33 kg per tray)<br>2.25 kg single package metal or polymer instruments<br>and dental handpieces (max 1.33 kg per tray)<br>1.25 kg double package metal or polymer instruments<br>and dental handpieces (max 1.33 kg per tray)<br>0.75 kg unwrapped porous and fabric textiles<br>0.60 kg single package porous and fabric textiles<br>0.50 kg double package porous and fabric textiles |
| | (C4) SOLID<br>134<br>(1 prevacuum<br>step; -0.8 bar) | 134°C / 273°F<br>4 minutes | 14.5 min | 4.50 kg unwrapped metal or polymer instruments<br>(max 1.33 kg per tray)<br>2.25 kg single package metal or polymer instruments<br>(max 1.33 kg per tray) |
| | (C5)<br>HOLLOW 134<br>(3 prevacuum<br>steps; -0.8 bar<br>each step) | 134°C / 273°F<br>4 minutes | 3 min | 4.50 kg unwrapped metal or polymer instruments and<br>dental handpieces (max 1.33 kg per tray) |
| | HELIX/BD<br>TEST<br>(3 prevacuum<br>steps; -0.8 bar | 134°C / 273°F<br>3.5 minutes | 1.5 min | Test device only (without another load) |

{17}------------------------------------------------

| each step) | | |
|-------------------------------------|---|-------------------------------------------------------|
| VACUUM<br>TEST<br>(-0.8 bar) | / | Empty chamber<br>Vacuum -0.8 bar<br>Test Time: 27 min |
| VACUUM +<br>HELIX/BD<br>TEST (****) | / | / |

Table 3 - B CLASSIC-22 Factory programmed sterilization cycles and parameters

(*) Default drying time, but the drying time can be manually increased

(**) Cycles C1, C2 are validated to sterilize up to 6 single sided lumened devices with inner diameter/length of the lumen: ≥1.25 mm/≤118 mm (corresponding to "hollow A" cavities with a length/diameter (L/D) ratio = 1 ≤ L/D ≤ 750).

Cycles C4 and C5 are validated to sterilize up to 6 double sided lumened devices with inner diameter/length of the lumen: ≥10 mm / ≤115 mm

(***) If the material is sterilized "unwrapped" the sterilized material shall used immediately after sterilization (the cycle shall be considered as immediate use cycle)

(****) This program enables to execute, in sequence, Vacuum test and Helix/BD test (nevertheless each test is executed separately)

B FUTURA-17 is a steam sterilizer that is intended for use by a health care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process.

The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.

#### B FUTURA-17 model

Chamber Dimensions (Depth 350mm / Diameter 250mm / Volume about 17 liters)

| MODEL NAME | CYCLE<br>NAME | STERILIZATION<br>TEMPERATURE /<br>EXPOSURE TIME | DRYING<br>TIME (*) | DESCRIPTION OF MAXIMUM LOAD AND TYPE<br>(**) (***) |
|-------------|---------------------------------------------------------------------------|-------------------------------------------------|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B Futura-17 | (C1)<br>UNIVERSAL<br>134<br>(3 prevacuum<br>steps; -0.8 bar<br>each step) | 134°C / 273°F<br>4 minutes | 9.67 min | 4 kg unwrapped metal or polymer instruments and<br>dental handpieces (max 1.33 kg per tray)<br>2 kg single package metal or polymer instruments<br>and dental handpieces (max 1.33 kg per tray)<br>1kg double package metal or polymer instruments<br>and dental handpieces (max 1.33 kg per tray)<br>0.6 kg unwrapped porous and fabric textiles<br>0.5 kg single package porous and fabric textiles<br>0.4 kg double package porous and fabric textiles |
| | (C2)<br>UNIVERSAL<br>121<br>(3 prevacuum<br>steps; -0.8 bar<br>each step) | 121°C / 250°F<br>20 minutes | 9.67 min | 4 kg unwrapped metal or polymer instruments and<br>dental handpieces (max 1.33 kg per tray)<br>2 kg single package metal or polymer instruments<br>and dental handpieces (max 1.33 kg per tray)<br>1kg double package metal or polymer instruments<br>and dental handpieces (max 1.33 kg per tray)<br>0.6 kg unwrapped porous and fabric textiles<br>0.5 kg single package porous and fabric textiles<br>0.4 kg double package porous and fabric textiles |
| | (C4) SOLID<br>134<br>(1 prevacuum<br>step; -0.8 bar) | 134°C / 273°F<br>4 minutes | 9.67 min | 4 kg unwrapped metal or polymer instruments<br>(max 1.33 kg per tray)<br>2 kg single package metal or polymer instruments<br>(max 1.33 kg per tray) |

{18}------------------------------------------------

| (C5)<br>HOLLOW 134<br>(3 prevacuum<br>steps; -0.8 bar<br>each step) | 134°C/273°F<br>4 minutes | 3 min | 4 kg unwrapped metal or polymer instruments and dental handpieces (max 1.33 kg per tray) |
|---------------------------------------------------------------------|----------------------------|----------|------------------------------------------------------------------------------------------|
| HELIX/BD<br>TEST<br>(3 prevacuum<br>steps; -0.8 bar<br>each step) | 134°C/273°F<br>3.5 minutes | 1.33 min | Test device only (without another load) |
| VACUUM<br>TEST<br>(-0.8 bar) | / | / | Empty chamber<br>Vacuum -0.8 bar<br>Test Time: 27 min |
| VACUUM +<br>HELIX/BD<br>TEST (****) | / | / | / |

#### Table 2 - B FUTURA-17 Factory programmed sterilization cycles and parameters

(*) Default drying time, but the drying time can be manually increased

(**) Cycles C1, C2 are validated to sterilize up to 6 single sided lumened devices with inner diameter/length of the lumen: ≥1.25 mm/≤118 mm (corresponding to "hollow A" cavities with a length/diameter (L/D) ratio = 1 ≤ L/D ≤ 750).

Cycles C4 and C5 are validated to sterilize up to 6 double sided lumened devices with inner diameter/length of the lumen: ≥10 mm / ≤115 mm

(***) If the material is sterilized "unwrapped" the sterilized material shall used immediately after sterilization (the cycle shall be considered as immediate use cycle)

(****) This program enables to execute, in sequence, Vacuum test and Helix/BD test (nevertheless each test is executed separately)

B FUTURA-22 is a steam sterilizer that is intended for use by a health care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process.

The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.

#### B FUTURA-22 model

Chamber Dimensions (Depth 450mm / Diameter 250mm / Volume about 22 liters)

| MODEL NAME | CYCLE<br>NAME | STERILIZATION<br>TEMPERATURE /<br>EXPOSURE TIME | DRYING<br>TIME (*) | DESCRIPTION OF MAXIMUM LOAD AND TYPE<br>(**) (***) |
|--------------------|---------------------------------------------------------------------------|-------------------------------------------------|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>B Futura-22</b> | (C1)<br>UNIVERSAL<br>134<br>(3 prevacuum<br>steps; -0.8 bar<br>each step) | 134°C / 273°F<br>4 minutes | 11.5 min | 4.5 kg unwrapped metal or polymer instruments and<br>dental handpieces (max 1.33 kg per tray)<br>2.25 kg single package metal or polymer instruments<br>and dental handpieces (max 1.33 kg per tray)<br>1.25 kg double package metal or polymer instruments<br>and dental handpieces (max 1.33 kg per tray)<br>0.75 kg unwrapped porous and fabric textiles<br>0.60 kg single package porous and fabric textiles<br>0.50 kg double package porous and fabric textiles |
| | (C2)<br>UNIVERSAL<br>121 | 121°C / 250°F<br>20 minutes | 11.5 min | 4.5 kg unwrapped metal or polymer instruments and<br>dental handpieces (max 1.33 kg per tray)<br>2.25 kg single package metal or polymer instruments |

{19}------------------------------------------------

| (3 prevacuum<br>steps; -0.8 bar<br>each step) | | | and dental handpieces (max 1.33 kg per tray)<br>1.25 kg double package metal or polymer instruments<br>and dental handpieces (max 1.33 kg per tray)<br>0.75 kg unwrapped porous and fabric textiles<br>0.60 kg single package porous and fabric textiles<br>0.50 kg double package porous and fabric textiles |
|---------------------------------------------------------------------|------------------------------|----------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (C4) SOLID<br>134<br>(1 prevacuum<br>step; -0.8 bar) | 134°C / 273°F<br>4 minutes | 11.5 min | 4.50 kg unwrapped metal or polymer instruments<br>(max 1.33 kg per tray)<br>2.25 kg single package metal or polymer instruments<br>(max 1.33 kg per tray) |
| (C5)<br>HOLLOW 134<br>(3 prevacuum<br>steps; -0.8 bar<br>each step) | 134°C / 273°F<br>4 minutes | 3 min | 4.50 kg unwrapped metal or polymer instruments and<br>dental handpieces (max 1.33 kg per tray) |
| (3 prevacuum<br>steps; -0.8 bar<br>each step)<br>HELIX/BD<br>TEST | 134°C / 273°F<br>3.5 minutes | 1.33 min | Test device only (without another load) |
| (3 prevacuum<br>steps; -0.8 bar<br>each step)<br>VACUUM<br>TEST | / | / | Empty chamber<br>Vacuum -0.8 bar<br>Test Time: 27 min |
| (-0.8 bar)<br>VACUUM +<br>HELIX/BD<br>TEST (****) | / | / | / |

Table 4 - B FUTURA-22 Factory programmed sterilization cycles and parameters (*) Default drying time, but the drving time can be manually increased

(**) Cycles C1, C2 are validated to sterilize up to 6 single sided lumened devices with inner diameter/length of the lumen: ≥1.25 mm/≤118 mm (corresponding to "hollow A" cavities with a length/diameter (L/D) ratio = 1 ≤ L/D ≤ 750).

Cycles C4 and C5 are validated to sterilize up to 6 double sided lumened devices with inner diameter/length of the lumen: ≥10 mm / ≤115 mm

(***) If the material is sterilized "unwrapped" the sterilized material shall used immediately after sterilization (the cycle shall be considered as immediate use cycle)

(****) This program enables to execute, in sequence, Vacuum test and Helix/BD test (nevertheless each test is executed separately)

#### 2.5. Device Description

The Family of steam sterilizers B17 B22 series includes table-top steam sterilizers that use saturated steam at high pressures and temperatures to kill infectious bio-organisms. The Classic and B Futura models differ only for some minor characteristics such as color touchscreen, optional Wi-FI connection, illumination of the working area and Ethernet connection.

The steam is generated by a steam generator connected to the sterilization chamber without disconnecting devices. An electric heating element surrounds the chamber for preheating of the chamber and maintaining the temperature. The subject family is characterized by a fractionated vacuum system for the complete air removal also from hollow and porous materials as well as by a final vacuum drying phase able to eliminate any trace of condensation from the load.

{20}------------------------------------------------

| Features | Subject Device | | Predicate Device<br>(K151597) | Substantially<br>Equivalent |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| | B FUTURA-17<br>B CLASSIC-17 | B FUTURA-22<br>B CLASSIC-22 | B FUTURA-28<br>B CLASSIC-28 | |
| Regulation<br>number | 880.6880 – Steam Sterilizers | 880.6880 – Steam Sterilizers | 880.6880 – Steam Sterilizers | Same |
| Class | II | II | II…