INSTRUMENT HOLDER

K970900 · Contour Fabricators, Inc. · GCJ · May 22, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K970900
• Device Name: INSTRUMENT HOLDER
• Applicant: Contour Fabricators, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: May 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The disposable, sterile instrument holder is intended to be an easily positioned sterile support for surgical instruments. Pressure sensitive adhesive strips are included to allow easy application of the holder to a dry operating room surface.

Device Story

Sterile, disposable vinyl instrument holder; 7.25” x 8.5” dimensions; features 6 heat-sealed pockets for storage/retrieval of lightweight surgical instruments (e.g., microsurgical tools, bipolar forceps, suction tips). Includes pressure-sensitive adhesive strips for attachment to dry operating room surfaces. Used by surgical staff to organize and support instruments during procedures; facilitates easy access and retrieval. Benefits include improved instrument management and maintenance of sterile field.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: 8 mil vinyl. Dimensions: 7.25" x 8.5". Configuration: 6 heat-sealed pockets of varying sizes. Attachment: Pressure-sensitive adhesive strips. Sterilization: Sterile (disposable).

Indications for Use

Indicated for use as a sterile support for surgical instruments, such as lightweight microsurgical instruments, bipolar forceps, or suction tube tips, in an operating room setting.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Technadyne Endoscopic Instrument Holder (K940891)

Submission Summary (Full Text)

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510(K) SUMMARY
(as required by 807.92(c))
kg 76900

**Submitter of 510(k):**
Contour Fabricators, Inc.
4100 East Baldwin Rd.
Grand Blanc, MI 48439
Phone: [phone]
Fax: [phone]
MAY 22 1997

**Contact Person:** Michael W. Czop
**Date of Summary:** March 7, 1997
**Trade Name:** Instrument Holder
**Classification Name:** n/a
**Predicate Device:** Tecnadyne Scientific Incorporated,
“Technadyne Endoscopic Instrument Holder”
K940891

**Device Description:** The sterile, disposable instrument holder is made of 8 mil vinyl. The overall dimensions of the device are 7.25” x 8.5”. The vinyl is heat sealed to create 6 pockets to allow for easy instrument storage and retrieval. Pocket sizes are as follows:

(1) pocket at 4”x3.75”
(1) pocket at 4”x6”
(2) pockets at 2”x3.75”
(2) pockets at 2”x6”

**Intended Use:** The disposable, sterile instrument holder is intended to be an easily positioned sterile support for surgical instruments. Pressure sensitive adhesive strips are included to allow easy application of the holder to a dry operating room surface.

Examples of possible instruments held by this device are lightweight microsurgical instruments, bipolar forceps, or suction tube tips.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

MAY 22 1997

Mr. Michael W. Czop
Contour Fabricators, Inc.
PO Box 56
Grand Blanc, Michigan 48439

Re: K970900
Trade Name: Instrument Holder
Regulatory Class: II
Product Code: GCJ
Dated: March 7, 1997
Received: March 11, 1997

Dear Mr. Czop:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Michael W. Czop

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): 5970900

Device Name: Instrument Holder

Indications for Use:

The disposable, sterile instrument holder is intended to be an easily positioned sterile support for surgical instruments. Pressure sensitive adhesive strips are included to allow easy application of the holder to a dry operating room surface.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


Prescription Use
(Per 21 CFR 801.109)

☑ OR

Over-The-Counter Use

Optional Format 1-2-96