CONMED DETACHATIP INSTRUMENT TRAY, 33CM AND 43CM

K092414 · Conmed Corporation · KCT · Mar 10, 2010 · General Hospital

Device Facts

• Record ID: K092414
• Device Name: CONMED DETACHATIP INSTRUMENT TRAY, 33CM AND 43CM
• Applicant: Conmed Corporation
• Product Code: KCT · General Hospital
• Decision Date: Mar 10, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The ConMed™ DetachaTip® Instrument Trays are perforated containment devices for medical device sterilization. ConMed" DetachaTip® Instrument Trays are a family of containment devices used to conveniently organize, sterilize, and transport Detachatip instruments between uses. The ConMed instrument trays are not intended to maintain sterility. We do not recommend that the trays be used to store sterilized contents. The 33cm DetachaTip Instrument Tray (1-1027) is designed for use with ConMed's 33cm DetachaTip multiuse scissors, DetachaTip multiuse graspers, DetachaTip multiuse dissectors and DetachaTip handles. The trays are intended to be used specifically with the following: [List of 33cm instruments]. The 43cm DetachaTip Instrument Tray (1-4327) are designed for use only with The 15cm DetachaTip multiuse scissors, DetachaTip multiuse graspers, Convice 3 +20m Detacha is is and DetachaTip handles. The trays are intended to be used specifically with the following: [List of 43cm instruments].

Device Story

Perforated containment trays for organizing, sterilizing, and transporting ConMed DetachaTip surgical instruments; used in clinical settings by healthcare staff. Trays feature Radel R Polyphenylsulfone base/lid, silicone mat, and stainless steel handles. Instruments are placed in tray; lid locked; tray subjected to prevacuum steam sterilization (132°C, 4 min exposure, 20 min dry). Perforations facilitate steam penetration. Device is reusable; not intended for long-term storage of sterile contents. Benefits include organized instrument handling and effective sterilization processing.

Clinical Evidence

Bench testing only. Validation performed using biological indicators and thermocouples to confirm sterilization efficacy and drying performance during prevacuum steam sterilization cycles (132°C, 4-minute exposure, 20-minute dry time).

Technological Characteristics

Materials: Radel R Polyphenylsulfone (base, tray, lid), silicone rubber (mat), stainless steel (handles). Design: Perforated lid/base for steam penetration; locking lid mechanism. Dimensions: 33cm and 43cm tray variants. Sterilization: Prevacuum steam (132°C).

Indications for Use

Indicated for use as a containment device to organize, sterilize, and transport specific ConMed DetachaTip multiuse surgical instruments (scissors, graspers, dissectors, handles) in 33cm and 43cm lengths. Not intended for maintaining sterility or storage of sterilized contents.

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

• Paragon Medical Surgical Instrument Delivery Tray (K032119)

Submission Summary (Full Text)

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K09241.14

Image /page/0/Picture/1 description: The image shows the logo for Conmed Corporation. The logo consists of a stylized "C" shape in a black square on the left, followed by the word "CONMED" in large, bold letters. Below the word "CONMED" is the word "CORPORATION" in smaller letters. There is a registered trademark symbol next to the "D" in "CONMED".

MAR 1 0 2010

# 510(k) Summary of Safety and Effectiveness

# ConMed™ Detachatip® Instrument Trays

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. ConMed Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the 510(k) Number

# A. Submitter

ConMed Corporation 525 French Road Utica, NY 13502 Registration Number: 1320894 Date: August 6, 2009

# B. Company Contact

Sandy Coveleski Regulatory Affairs Specialist ConMed Corporation 525 French Road Utica, NY 13502

Phone: [phone] Fax: [phone] e-mail: [e-mail]

### C. Device Name

| Trade Name: | ConMed™ Detachatip® Instrument Trays |
|------------------------|---------------------------------------------------------------------------|
| Common Name: | Instrument Sterilization Tray |
| Classification Name: | Sterilization Wrap Containers, Trays, Cassettes,<br>and other Accessories |
| Proposed Class/Device: | Class II |
| Product Code: | KCT |
| Regulation Number: | 21 CFR 880.6850 |
| Panel: | 880 General Hospital |

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### D. Predicate Device

Paragon Medical Surgical Instrument Delivery Tray Paragon Medical 510(K) # K032119

## E. Intended Use

The ConMed™ DetachaTip® Instrument Trays are perforated containment devices for medical device sterilization. ConMed" DetachaTip® Instrument Trays are a family of containment devices used to conveniently organize, sterilize, and transport Detachatip instruments between uses. The ConMed instrument trays are not intended to maintain sterility. We do not recommend that the trays be used to store sterilized contents.

The 33cm DetachaTip Instrument Tray (1-1027) is designed for use with ConMed's 33cm DetachaTip multiuse scissors, DetachaTip multiuse graspers, DetachaTip multiuse dissectors and DetachaTip handles. The trays are intended to be used specifically with the following:

| CAT. NO. | DESCRIPTION |
|----------|-----------------------------------|
| 2-1003 | METZENBAUM, 33CM LENGTH |
| 2-1004 | MINI-METZENBAUM, 33CM LENGTH |
| 2-1005 | 5MM BABCOCK GRASPER, 33CM LENGTH |
| 2-1008 | FENESTRATED GRASPER, 33CM LENGTH |
| 2-1009 | CURVED DISSECTOR, 33CM LENGTH |
| 1-1010 | STANDARD HANDLE |
| 2-1013 | HOOK, 33CM LENGTH |
| 2-1014 | 10MM BABCOCK, 33CM LENGTH |
| 1-1015 | COMPACT HANDLE |
| 2-1017 | RIGHT ANGLE MEEKER DISSECTOR 33CM |
| 2-1018 | TAPERED DISSECTOR, 33CM LENGTH |
| 2-1019 | ALLIS GRASPER, 33CM LENGTH |
| 1-1024 | IN-LINE HANDLE |
| 1-1028 | ENDOWEAVE GRASPER, 33 CM LENGTH |

The 43cm DetachaTip Instrument Tray (1-4327) are designed for use only with The 15cm DetachaTip multiuse scissors, DetachaTip multiuse graspers, Convice 3 +20m Detacha is is and DetachaTip handles. The trays are intended to be used specifically with the following:

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| CAT. NO. | DESCRIPTION |
|----------|-----------------------------------|
| 2-4301 | METZENBAUM, 43CM LENGTH |
| 2-4304 | MINI-METZENBAUM, 43CM LENGTH |
| 2-4305 | 5MM BABCOCK GRASPER, 43CM |
| 2-4308 | CURVED DISSECTOR, 43CM LENGTH |
| 2-4307 | FENESTRATED GRASPER, 43CM LENGTH |
| 2-4314 | 10MM BABCOCK, 43CM |
| 2-4317 | RIGHT ANGLE MEEKER DISSECTOR 43CM |
| 2-4318 | TAPERED DISSECTOR, 43CM |
| 2-4319 | ALLIS GRASPER, 43CM |
| 2-4328 | ENDOWEAVE GRASPER, 43CM |

Materials The ConMed™ DETACHATIP® INSTRUMENT TRAYS consist of a Radel R Polyphenylsulfone base, a Radel R Polyphenylsulfone tray, a silicone rubber mat, a Radel R Polyphenylsulfone lid with tray lid clips with perforations to facilitate steam penetration, and stainless steel carrying handles. The tray holds the ConMed™ DETACHATIP® surgical instruments before, during, and after the sterilization process. The tray set has a locking lid to contain the instruments.

Sterilant Penetration The the ConMed™ DETACHATIP® INSTRUMENT TRAYS have been validated to perform effectively during prevacuum steam sterilization and drying cycles, using biological indicators and thermocouples to support sterilization and drying processes.

#### Pre-vacuum

Min temperature =132°C Min. exposure = 4 minutes Min. dry time = 20 minutes

CAUTION: Testing demonstrates that a minimum dry time of 20 minutes is required to prevent wet packs when using the prevacuum cycle.

Note: Validation was conducted using wrapped trays. The device should Note: Vanadion was other with FDA cleared wrap indicated for these sterilization cycles.

SheIf Life The sterilization tray is reusable and will not be serviced or repaired.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

MAR 1 0 2010

Ms. Sandy Coveleski Regulatory Affairs Specialist ConMed Corporation 525 French Road Utica, New York 13502

Re: K092414

Trade/Device Name: ConMedTM DetachaTip® Instrument Trays 33cm DetachaTip Instrument Tray (1-1027) 43cm Detachatip Instrument Tray (1-4327) Regulation Number: 21CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: February 16, 2010 Received: February 17, 2010

Dear Ms. Coveleski:

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. Coveleski

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 /ucm ! 1 5809.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/ResourcesforYou/Industry/default.htm.

Sincerely vours

Susan Runser

Anthony D. 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

### Enclosure

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# INDICATIONS FOR USE

| 510(k) Number (if known): | | 092414 | | | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--------------------------------------------------------------------------------------------------|--|--|--|--|--|--|
| | | | | | | | | |
| A Property Company Company Company Company Company Company Company Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Co | | C 11 1 M . 1 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . | | | | | | |

| Family Name: | ConMed" DetachaTip® Instrument Trays |
|--------------|------------------------------------------|
| Trade Name: | 33cm DetachaTip Instrument Tray (1-1027) |
| | 43cm DetachaTip Instrument Tray (1-4327) |

### Indications for Use

The ConMed" DetachaTip® Instrument Trays are perforated containment devices for medical device sterilization. ConMed" DetachaTip® Instrument Trays are a family of containment devices used to conveniently organize, sterilize, and transport Detachatip instruments between uses. The ConMed instrument trays are not intended to maintain sterility. We do not recommend that the trays be used to store sterilized contents.

The 33cm DetachaTip Instrument Tray (1-1027) is designed for use with ConMed's 33cm DetachaTip multiuse scissors, DetachaTip multiuse graspers, DetachaTip multiuse dissectors and DetachaTip handles. The trays are intended to be used specifically with the following:

| Cat. No. | Description |
|----------|-----------------------------------|
| 2-1003 | Metzenbaum, 33cm length |
| 2-1004 | Mini- Metzenbaum, 33cm length |
| 2-1005 | 5mm Babcock Grasper, 33cm length |
| 2-1008 | Fenestrated Grasper, 33cm length |
| 2-1009 | Curved Dissector, 33cm length |
| 1-1010 | Standard Handle |
| 2-1013 | Hook, 33cm length |
| 2-1014 | 10mm Babcock, 33cm length |
| 1-1015 | Compact Handle |
| 2-1017 | Right Angle Meeker dissector 33cm |
| 2-1018 | Tapered Dissector, 33cm length |
| 2-1019 | Allis Grasper, 33cm length |
| 1-1024 | In-line Handle |
| 1-1028 | Endoweave Grasper, 33 cm length |

The 43cm DetachaTip Instrument Tray (1-4327) are designed for use only with ConMed's 43cm DetachaTip multiuse scissors, DetachaTip multiuse graspers, DetachaTip multiuse dissectors and DetachaTip handles. The trays are intended to be used specifically with the following:

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

## INDICATIONS FOR USE

| Cat. No. | Description |
|----------|-----------------------------------|
| 2-4301 | Metzenbaum, 43cm length |
| 2-4304 | Mini- Metzenbaum, 43cm length |
| 2-4305 | 5mm Babcock Grasper, 43cm |
| 2-4308 | Curved Dissector, 43cm length |
| 2-4307 | Fenestrated Grasper, 43cm length |
| 2-4314 | 10mm Babcock, 43cm |
| 2-4317 | Right Angle Meeker dissector 43cm |
| 2-4318 | Tapered Dissector, 43cm |
| 2-4319 | Allis Grasper, 43cm |
| 2-4328 | Endoweave Grasper, 43cm |

Sterilize the 33cm DetachaTip Instrument Tray (1-1027) and the 43cm DetachaTip Instrument Tray (1-4327) using the following parameters:

| Method | Cycle | Temperature | Exposure Time | Dry Cycle Time |
|-----------------|------------|--------------|---------------|----------------|
| Steam (wrapped) | Pre-vacuum | 270°F(132°C) | 4 minutes | 20 minutes |

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-the-Counter Use__X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Eshlata T. Queda-Wells

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

510(k) Number: K092414