SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY

K102544 · Smith & Nephew Inc., Endoscopy Div. · KCT · Jan 5, 2011 · General Hospital

Device Facts

• Record ID: K102544
• Device Name: SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY
• Applicant: Smith & Nephew Inc., Endoscopy Div.
• Product Code: KCT · General Hospital
• Decision Date: Jan 5, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

Smith & Nephew Hip Arthroscopy Repair Instrument Tray is intended to contain Smith & Nephew reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The subject instrument tray is suitable for use in a prevacuum steam sterilization method. The subject 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.

Device Story

Stainless steel tray with instrument holders, pin mats, and tiers; designed to contain and protect reusable surgical instruments during transport, sterilization, and storage. Used in clinical settings by healthcare staff to organize instruments for prevacuum steam sterilization. Tray requires use of a validated sterilization wrap to maintain sterility post-process. Benefits include organized instrument management and protection of surgical tools during the sterilization cycle.

Clinical Evidence

Bench testing only. Validation conducted for sterilization efficacy and functional strength in accordance with AAMI ST77:2006. No clinical data presented.

Technological Characteristics

Stainless steel construction; includes instrument holders, pin mats, and tiers. Designed for prevacuum steam sterilization (132°C/270°F, 4-minute exposure, 45-minute drying time).

Indications for Use

Indicated for the containment, organized storage, sterilization, and transport of reusable surgical instruments. No specific patient population, age, or disease state is defined as the device is a sterilization accessory.

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

• CROSSTRACTM Hip Access System Tray (K090562)
• Elite Premium II Shoulder Arthroscopy System (K091627)

Submission Summary (Full Text)

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K102544 >< We are smith&nephew

Endoscopy Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810

SECTION IV

978 749 1000 978 749 1599 Fax www.smith-nephew.com

#### JAN 5 2011

l r

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

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 Hip Arthroscopy Repair Instrument Tray

Date Prepared: September 2, 2010

## A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810

#### B. Company Contact

Kathleen Solomon Regulatory Affairs Specialist II T: 978-749-1605 F: 978-749-1443 [e-mail]

#### C. Device Name

| Trade Name: | Smith & Nephew Hip Arthroscopy Repair Instrument Tray |
|------------------------|-------------------------------------------------------|
| Common Name: | Sterilization Tray |
| Classification Name: | Sterilization Wrap |
| Class: | II |
| Product Code: | KCT |
| Classification Number: | 21 CFR §880.6850 |

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### D. Predicate Devices

The Smith & Nephew Hip Arthroscopy Repair Instruments 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): CROSSTRACTM Hip Access System Tray

K091627 (cleared July 2, 2009) Elite Premium II Shoulder Arthroscopy System

## E. Description of Device

Smith & Nephew Hip Arthroscopy Repair Instrument Repair Tray is a stainless steel tray provided with instrument holders, pin mat, and tiers. 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 devices. The number of instrument holders, pin mats, and organizing racks are similar to the predicates. The material of construction, and the type of instruments contained, and the indications for use statement are unchanged from the predicate trays.

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.

#### ﺘﻘ Intended Use

Smith & Nephew Hip Arthroscopy Repair Instrument Tray is intended to contain Smith & Nephew reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The subject instrument tray is suitable for use in a prevacuum steam sterilization method. The subject 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.

Validated Sterilization Parameters:

| Method | Temperature | Exposure Time | Drying<br>Time |
|---------------------|----------------------|---------------|----------------|
| Pre-vacuum<br>steam | 132 ° C<br>(270 ° F) | 4 minutes | 45 minutes |

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### G. Comparison of Technological Characteristics

The subject Smith & Nephew Hip Arthroscopy Repair Instrument trays have 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 AAMI ST77:2006 Containment Devices for reusable medical device sterilization.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

...

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

Ms. Kathleen Solomon Regulatory Affairs Specialist II Smith & Nephew, Incorporated Endoscopy Division l 50 Minuteman Road Andover, Massachusetts 01810

Re: K102544

Trade/Device Name: Smith & Nephew Hip Arthroscopy Repair Instrument Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: December 23, 2010 Received: December 27, 2010

Dear Ms Solomon:

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. Solomon

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 regions . 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 53) -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 phone;" (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 yours,

for

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

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#### Indications for Use

510(k) Number (if known):

K102544

Device Name: Smith & Nephew Hip Arthroscopy Repair Instrument Tray

Indications For Use: Smith & Nephew Hip Arthroscopy Repair Instrument Tray is intended to contain Smith & Nephew reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The subject instrument tray is suitable for use in pre-vacuum steam sterilization method. The subject 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.

Validated Sterilization Parameters:

| Method | Temperature | Exposure Time | Drying Time |
|---------------------|--------------------|---------------|-------------|
| Pre-vacuum<br>steam | 132° C<br>(270° F) | 4 minutes | 45 minutes |

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

| REF | Description |
|----------|----------------------------------------|
| 72202732 | Hip Arthroscopy Repair Instrument Tray |

Prescription Use

AND/OR

(Per 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

Over-The-Counter Use X

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ealyabeth S. Clanni-Willen
(Division Sign-Off)

Division of Anesthesiology, General Hospital
Infection Control and Dental Devices
510(k) Number. K102544

Smith & Nephew Hip Arthroscopy Repair Instrument Tray

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