GYNECOLOGY STERILIZATION TRAY

K121904 · Smith & Nephew Inc., Endoscopy Division · KCT · Mar 11, 2013 · General Hospital

Device Facts

• Record ID: K121904
• Device Name: GYNECOLOGY STERILIZATION TRAY
• Applicant: Smith & Nephew Inc., Endoscopy Division
• Product Code: KCT · General Hospital
• Decision Date: Mar 11, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Smith & Nephew instrument tray is intended to contain Smith & Nephew reusable surgical instrumentation for convenient organized storage, sterilization and transport between usages. The instrument tray must be doubled wrapped with an FDA cleared polypropylene sterilization wrap. The instrument wrap is suitable for use in pre-vacuum steam sterilization method. The instrument tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated sterilization wrap in order to maintain sterility of the enclosed devices. Maintenance of sterility is dependent on the sterilization wrap shelf life and not the tray. Users must follow the instructions for use supplied with the sterilization wrap and follow the manufacturer's recommended storage conditions and time frames for shelf life. The maximum number of devices that could be processed in one load is five. The maximum weight load is 8.4lbs.

Device Story

Stainless steel tray with instrument holders, internal compartments, and pin mat; designed to contain and protect reusable surgical instruments during transport, sterilization, and storage. Used in clinical settings by healthcare personnel. Tray requires double-wrapping with FDA-cleared polypropylene sterilization wrap; compatible with pre-vacuum steam sterilization (132°C for 4 minutes, 30-minute drying time). Tray does not maintain sterility independently; sterility maintenance relies on the external wrap. Benefits include organized instrument handling and protection during sterilization cycles.

Clinical Evidence

No clinical data. Bench testing only. Performance testing conducted in accordance with ANSI/AAMI ST77:2006 for sterilization and functional strength to verify pre-defined acceptance criteria.

Technological Characteristics

Stainless steel tray with instrument holders and pin mat. Dimensions and material composition are similar to predicate. Compatible with pre-vacuum steam sterilization. No electronic components or software.

Indications for Use

Indicated for the containment, organized storage, sterilization, and transport of up to five Smith & Nephew reusable surgical instruments (hysteroscope, handpiece, sheath, calibration insert/obturator, diagnostic sheath) with a maximum total weight of 8.4 lbs.

Regulatory Classification

Identification

A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Predicate Devices

• ELITE Premium Biceps Tenodesis System (K090562)

Submission Summary (Full Text)

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# SECTION IV

#### MAR 1 1 2013 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

K121904

as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

## Smith & Nephew Gynecology Instrument Tray

Date Prepared: June 27, 2012

- A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division

150 Minuteman Road

Andover, MA 01810

# B. Company Contact

Janice Haselton

Sr. Regulatory Affairs Specialist

T: 978-749-1494

F: 978-749-1443

[e-mail]

#### C. Device Name

| Trade Name: | Smith & Nephew Gynecology Instrument Tray |
|------------------------|-------------------------------------------|
| Common Name: | Sterilization Tray |
| Classification Name: | Sterilization Wrap |
| Class: | 2 |
| Product Code: | KCT |
| Classification Number: | 21 CFR §880.6850 |

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#### D. Predicate Devices

The Smith & Nephew Gynecology Instrument Tray is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution:

K090562 (cleared March 18, 2009): ELITE Premium Biceps Tenodesis System

#### E. Description of Device

The Smith & Nephew Gynecology Instrument Tray is a stainless steel tray provided with instrument holders, internal compartment and a pin mat. The tray is designed to contain and protect reusable surgical instruments during transport, sterilization, and storage and to allow optimal exposure of the tray's contents to sterilant during the sterilization process.

The technological characteristics of the subject tray are identical to the predicate device. The number of instrument holders and pin mats and material of construction are similar to the predicate. The indications for use statement is unchanged from the predicate tray.

Non clinical validation testing was conducted for sterilization and functional strength in order to demonstrate that the subject device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses.

#### F. Intended Use

# Indications For Use

Indications For Use The Smith & Nephew instrument tray is intended to contain Smith & Nephew reusable surgical instrumentation for convenient organized storage, sterilization and transport between usages. The instrument tray must be doubled wrapped with an FDA cleared polypropylene sterilization wrap.

> The instrument wrap is suitable for use in pre-vacuum steam sterilization method. The instrument tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated sterilization wrap in order to maintain sterility of the enclosed devices. Maintenance of sterility is dependent on the sterilization wrap shelf life and not the tray. Users must follow the instructions for use supplied with the sterilization wrap and follow the manufacturer's recommended storage conditions and time frames for shelf life. The maximum number of devices that could be processed in one load is five. The maximum weight load is 8.4lbs.

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### Validated Sterilization Parameters

| Instrument Tray Contents | Max loaded Tray Weight 8.4 lbs. |
|--------------------------------|------------------------------------------------------------------|
| Device Type | Dimensions |
| Hysteroscope | Length: 334mm Max., Diameter: 8mm<br>Max.<br>Lumen: 3.1mm Min. |
| Handpiece | Length: 203mm Max., Diameter: 32mm<br>Max.<br>Lumen: 5.1mm Max |
| Sheath | Length: 230mm Max., Diameter: 9mm<br>Max.<br>Lumen: 4.6mm Min. |
| Calibration Insert / Obturator | Length: 385mm Max., Diameter: 4.1mm<br>Max. |
| Diagnostic Sheath | Length: 390mm Max., Diameter: 2.9mm<br>Max.<br>Lumen: 1.9mm Min. |

Validated Sterilization Parameters:

| Method | Temperature | Exposure Time | Drying Time |
|---------------------|--------------------|---------------|-------------|
| Pre-vacuum<br>steam | 132° C<br>(270° F) | 4 minutes | 30 minutes |

# G. Comparison of Technological Characteristics

The subject Smith & Nephew Gynecology Instrument tray has the same fundamental technological characteristics as the unmodified predicate device. The subject tray is substantially equivalent in design, materials and intended use to the predicate device. There are no significant differences between the proposed and predicate devices that raise new questions of safety or efficacy.

# H. Summary Performance Data

Performance testing was conducted in accordance with ANSI/AAMI ST77:2006 Containment Devices for reusable medical device sterilization.

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

March 11, 2013

Ms. Janice Haselton Senior Regulatory Affairs Specialist Smith & Nephew Incorporated, Endoscopy Division 150 Minuteman Road ANDOVER MA 01810

Re: K121904

Trade/Device Name: Gynecology Instrument Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: February 25, 2013 Received: February 28, 2013

Dear Ms. Haselton:

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.

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Page 2 - Ms. Haselton

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 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 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 Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours,

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Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known):

K121904

Device Name: Smith & Nephew Gynecology Instrument Tray

Indications For Use

The Smith & Nephew instrument tray is intended to contain Smith & Nephew reusable surgical instrumentation for convenient organized storage, sterilization and transport between usages. The instrument tray must be doubled wrapped with an FDA cleared polypropylene sterilization wrap.

The instrument wrap is suitable for use in pre-vacuum steam sterilization method. The instrument tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated sterilization wrap in order to maintain sterility of the enclosed devices. Maintenance of sterility is dependent on the sterilization wrap shelf life and not the tray. Users must follow the instructions for use supplied with the sterilization wrap and follow the manufacturer's recommended storage conditions and time frames for shelf life. The maximum number of devices that could be processed in one load is five. The maximum weight load is 8.4lbs.

Validated Sterilization Parameters:

| Method | Temperature | Exposure Time | Drying Time |
|---------------------|--------------------|---------------|-------------|
| Pre-vacuum<br>steam | 132° C<br>(270° F) | 4 minutes | 30 minutes |

| Instrument Tray Contents | |
|------------------------------|----------------------------------------------------------------|
| Device Type | Dimensions |
| Hysteroscope | Length: 334mm Max.<br>Diameter: 8mm Max<br>Lumen: 3.1mm Min. |
| Handpiece | Length: 203mm Max.<br>Diameter: 32mm Max<br>Lumen: 5.1mm Min. |
| Sheath | Length: 230 mm Max.<br>Diameter: 9mm Max<br>Lumen: 4.6mm Min. |
| Calibration Insert/Obturator | Length: 385mm Max.<br>Diameter: 4.1mm Max |
| Diagnostic Sheath | Length: 390mm Max.<br>Diameter: 2.9mm Max<br>Lumen: 1.9mm Min. |

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Device model that is the subject of this pre-market notification:

| REF | Description |
|----------|----------------------------|
| 72203004 | Gynecology Instrument Tray |

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X

Over-The-Counter Use

(Per 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

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121904 510(k) Number: _

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