AMSCO WARMING CABINET

K092823 · STERIS Corporation · LGZ · Dec 18, 2009 · General Hospital

Device Facts

• Record ID: K092823
• Device Name: AMSCO WARMING CABINET
• Applicant: STERIS Corporation
• Product Code: LGZ · General Hospital
• Decision Date: Dec 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2

Intended Use

The Amsco Warming Cabinet is designed to raise the temperature of blankets, linens and sterile surgical irrigation solutions and IV solutions to an acceptable level for various surgical, obstetrical, emergency, critical care and other healthcare applications. The Amsco Warming Cabinet is designed to hold a combination of flasks and/or dry goods.

Device Story

Amsco Warming Cabinet stores and warms sterile IV solutions, surgical irrigation solutions, linens, and blankets. Device uses electric heater and fan blower for convection heating. User interface includes digital push-button keypad, power switch, and LCD temperature display. Features include temperature lock-out, door ajar indicator, over-temperature alarm (visual/audible), and data port for temperature retrieval. Used in hospitals and surgical outpatient centers. Healthcare staff operate device to ensure fluids/linens reach acceptable temperatures for patient care. Benefits include maintaining optimal temperature for clinical applications, reducing risk of hypothermia during procedures. Device configurations include single/double units, wall-mounted or free-standing/mobile, with stainless steel, ABS plastic, and laminated galvanized steel construction.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Heating: Electric heater and fan blower (convection). Materials: Stainless steel, ABS plastic, laminated galvanized steel. Dimensions: 18" or 24" depth. Connectivity: Data port for temperature retrieval. Controls: Digital push-button keypad, LCD display. Safety: Over-temperature alarm (visual/audible), automatic heater shut-off, temperature lock-out. Power: 110/120 Vac or 220/240 Vac, 50/60 Hz.

Indications for Use

Indicated for warming blankets, linens, sterile surgical irrigation solutions, and IV solutions for use in surgical, obstetrical, emergency, critical care, and other healthcare applications.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

• STERIS Amsco Warming Cabinet (Pre-Amendment)
• Enthermics EC-7701 Fluid Warming Cabinet (K993797)

Submission Summary (Full Text)

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the text "Public Health Service" in a bold, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall appearance is simple and straightforward, focusing on conveying the name of the organization.

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

Mr. Robert F. Sullivan Senior Director FDA Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060

## JAN 1 0 2017

Re: K092823

Trade/Device Name: Amsco Warming Cabinet Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ Dated: September 11, 2009 Received: September 14, 2009

Dear Mr. Sullivan:

This letter corrects our substantially equivalent letter of December 18, 2009.

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 your 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

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

Page 2 - Mr. Robert F. Sullivan

CFR Part 807); labeling (21 CFR Parts 801 and 809 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Parts 801 and 809), 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/ResourcesforYou/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 vours.

# Erin I. Keith -S

Erin I. Keith, M.S. 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):

Device Name:

Amsco Warming Cabinet

Indications For Use:

The Ansco Warming Cabinet is designed to raise the temperature of blankets, lineus and sterile surgical irrigation solutions and IV solutions to an acceptable level for various surgical, obstetrical, emergency, critical care and other healthcare applications

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Austin for Gz

(Division Sign-Off) Division of Anesthesiology, General Hospital Intection Control, Dental Devices

510(k) Number: 692823

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

Image /page/3/Picture/0 description: The image shows a handwritten text that appears to be a word or a combination of letters and symbols. The characters are written in a cursive style, with some letters connected to each other. The writing is dark and bold, contrasting with the white background, making it easily readable.

# STERIS.

DEC 1 8 2009

## 510(k) Summary For Amsco Warming Cabinet

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: [phone] Fax No: [phone]

Contact:

Robert F. Sullivan Senior Director FDA Regulatory Affairs Telephone: [phone] Fax No: 440-357-9198

Summary Date:

September 11, 2009

STERIS Corporation • 5960 Heisley Road • Mentor. OH 44060-1834 USA • 440-354-2600

September 11, 2009

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

#### Device Name 1.

| Trade Name: | Amsco Warming Cabinet |
|----------------------|-----------------------------|
| Common/usual Name: | Warming Cabinet |
| Classification Name: | Warmer, Irrigation Solution |

#### 2. Predicate Device

STERIS Amsco Warming Cabinet (Pre-Amendment) Enthermics EC-7701 Fluid Warming Cabinet, K993797, January 20, 2000

Warmer, Cabinet

#### 3. Description of Device

The Amsco Warming Cabinet is designed to store and warm sterile IV solutions, surgical irrigation solutions, linens and/or blankets to an acceptable level for hospital and surgical outpatient center applications.

The upper compartment of the 18" (457mm) deep model holds up to 24(1-liter) liquid bags or bottles and 14 (1-liter) IV solution bags; the lower compartment holds up to 72 (1-liter) liquid bags or bottles.

The upper compartment of the 24" (610mm) deep model holds up to 30 (1-liter) surgical flasks; the lower compartment holds up to 90 (1-liter) surgical flasks.

#### 4. Intended Use

The Amsco Warming Cabinet is designed to raise the temperature of blankets, linens and sterile surgical irrigation solutions and IV solutions to an acceptable level for various surgical, obstetrical, emergency, critical care and other healthcare applications.

#### ડ. Description of Safety and Substantial Equivalence

The Amsco Warming Cabinet is nearly identical to the two predicate devices in all material respects. A table comparing the technological characteristics of the proposed Amsco Warming Cabinet to the predicates is provided in Table 5-1.

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

### STERIS TRADITIONAL 510(k) PREMARKET SUBMISSION STERIS Amsco Warming Cabinet

| Features | Technological Characteristics | | |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Amsco Warming Cabinet<br>(IV Solution Capability) | Amsco Warming Cabinet<br>(Pre-amendment) | EC-7701 Fluid Warming<br>Cabinet (K993797) |
| Intended Use | The Amsco Warming Cabinet<br>is designed to raise the<br>temperature of blankets, linens<br>and sterile surgical irrigation<br>solutions and IV solutions to<br>an acceptable level for various<br>surgical, obstetrical,<br>emergency, critical care and<br>other healthcare applications.<br>The Amsco Warming Cabinet<br>is designed to hold a<br>combination of flasks and/or<br>dry goods. | Amsco Warming Cabinet is for<br>heating flasked solutions,<br>blankets and similar clinical<br>articles. | The Enthermics Medical<br>Systems EC-7701 Fluid<br>Warming Cabinet is<br>designed to safely store<br>and warm irrigation fluids<br>or injection fluids in<br>accordance with the<br>recommended warming<br>temperatures and storage<br>times stated in the fluid<br>manufacturer's labeling. |
| Heating<br>System | Electric heater and fan blower<br>(Convection heating) | Steam heat or Electric heater<br>blanket and fan blower<br>(Convection heating) | Fully insulated<br>electrothermal cable array<br>(Convection heating) |
| Unit<br>Configuration | Single/Double | Single/Dual | Single |
| Unit Depth | 18" or 24" | 18" or 24" | |
| Model | Wall or Counter | Wall or Counter | Wall |
| Interior and<br>Exterior<br>Surfaces | Stainless Steel, ABS Plastic<br>and laminated galvanized steel | Stainless Steel | Stainless Steel |
| Installation | Free-Standing (mobile) or<br>Recessed | Open-Mounted or Recessed | Free-standing (mobile) or<br>Recessed |
| Door | Stainless Steel (Solid and<br>Glass) | Stainless Steel | Stainless Steel (Glass) |
| Cabinet<br>Storage<br>Capacity | 18" upper / single chamber -<br>3.2 cu ft - up to 24 (1-liter)<br>bottles<br><br>18" lower chamber - 8.5 cu ft<br>- up to 72 (1-liter) bottles<br><br>24" upper / single chamber -<br>4.3 cu ft - up to 30 (1-liter)<br>bottles<br><br>24" lower chamber - 11.6 cu ft<br>- up to 90 ( 1-liter) bottles | Dual Compartment Model -<br>Two shelves<br>15 flasks - 18" upper<br>45 flasks - 18" lower<br>20 flasks - 24" upper<br>60 flasks - 24" lower<br><br>Single Compartment Model -<br>One shelf<br>15 flasks - 18"<br>20 flasks - 24" | The cabinet is equipped<br>with three (3) white,<br>epoxy-coated wire baskets,<br>each with a 24 liter<br>capacity. |
| Features | | | |
| Cabinet<br>Volume | Amsco Warming Cabinet<br>(IV Solution Capability)<br>18" upper chamber - 3.1 cu ft<br>24" upper chamber - 4.2 cu ft<br>18" lower chamber - 8.9 cu ft<br>24" lower chamber - 12 cu ft | Amsco Warming Cabinet (Pre-amendment)<br>18" upper chamber - 3.1 cu ft<br>24" upper chamber - 4.2 cu ft<br>18" lower chamber - 8.9 cu ft<br>24" lower chamber - 12 cu ft | EC-7701 Fluid Warming<br>Cabinet (K993797) |
| Controls | Digital Push Button keypad /<br>power switch / Digital LCD<br>temperature display / mode<br>selection buttons / door ajar<br>indicator / Over-temperature<br>light for each compartment /<br>Data port for retrieval of<br>stored temperatures. | Thermostat / power switch /<br>fuse with indicating light / color<br>coded temperature selector | Electronic control consists<br>of 4 digit LED display,<br>on/off key, increase and<br>decrease keys, integrated<br>lock feature and a series of<br>prompt sequence<br>indicators. |
| Software | Unit contains software | Not Applicable | Not applicable |
| Temperature<br>Selection<br>Range | 90°F (32°C) to 160°F (71°C) | 95°F to 150°F (35°C to 65°C) | 90°F (32°C) to 150°F<br>(66°C) |
| Temperature<br>Lock | Temperature lock-out function<br>to prevent unauthorized<br>temperature changes. | Not Available | The device allows the user<br>to "lock" the mode (IRR or<br>INJ) and temperature<br>setting controls.<br>Available as an option |
| Door Lock | All configurations will be<br>equipped with either a manual<br>mechanical door lock or<br>optional electronic door lock<br>system for each compartment | Available by SSQ (Special<br>Sales Quote) only | Available as an option |
| Over<br>Temperature<br>Alarm Point | Visual and audible alarm if<br>unit has a chamber<br>temperature greater than 10°F<br>(5.5°C) above set temperature.<br>In the event of an over temp<br>condition, sensors<br>automatically turns off the<br>heater(s). | Visual alarm if unit has a<br>chamber temperature greater<br>than 12°F above set<br>temperature. In the event of an<br>over temp condition, sensors<br>automatically turns off the<br>heater(s). | Visual and audible alarm if<br>unit has a chamber<br>temperature greater than<br>10°F (5.5°C) above set<br>temperature. In the event<br>of an over temp condition,<br>the heating system shuts<br>down. |
| Voltage<br>Requirements | 110/120 Vac, 220/240 Vac<br>nominal, 50/60 HZ | Electric Model: 110/120 Vac,<br>220/240 Vac nominal, 50/60<br>HZ<br>Steam Model: 120 VAC single<br>phase | 125 Vac, 60 HZ, 1 ph |

## Table 5-1 Summary of the Proposed Device and Predicate Devices Technological Characteristics

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

## STERIS TRADITIONAL 610(k) PREMARKET SUBMISSION
STERIS Amsco Warming Cabinet

.