CLINITEX STOCKINETTE

K973417 · Clinitex Medical Corp. · LGF · Dec 9, 1997 · Orthopedic

Device Facts

• Record ID: K973417
• Device Name: CLINITEX STOCKINETTE
• Applicant: Clinitex Medical Corp.
• Product Code: LGF · Orthopedic
• Decision Date: Dec 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.5940
• Device Class: Class 1

Intended Use

Clinitex® Stockinette is a tubular textile used to form the first protective layer (base) of an orthopedic cast below the cast padding and cast tape. The polyester material help repel water and dry rapidly.

Device Story

Clinitex Stockinette is a tubular textile sleeve applied directly to the skin as the initial layer beneath orthopedic cast padding and casting tape. Used in clinical settings by healthcare providers during orthopedic cast application. Polyester material construction provides water-repellent properties and rapid drying to protect the skin and maintain cast integrity. Serves as a mechanical barrier between the patient's limb and the rigid casting material.

Clinical Evidence

Bench testing only.

Technological Characteristics

Tubular textile sleeve composed of polyester material. Designed for use as a base layer in orthopedic casting. Non-sterile, passive mechanical device.

Indications for Use

Indicated for use as a base protective layer under orthopedic casts for patients requiring immobilization.

Regulatory Classification

Identification

A cast component is a device intended for medical purposes to protect or support a cast. This generic type of device includes the cast heel, toe cap, cast support, and walking iron.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Howell H. Michael General Manager Clinitex Medical Corporation 9801 Kincey Avenue, Suite 100 Huntersville, North Carolina 28078

Re : K973417 Clinitex® Stockinette K973420 Clinitex® Cast Padding Regulatory Class: I Product Code: LGF September 9, 1997 Dated: September 10, 1997 Received:

Dear Mr. Michael:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major requlations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) 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 devices in the Federal Register. Please note: this response to your premarket notification submission does

DEC - 9 1997

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Page 2 - Mr. Howell H. Michael

not affect any obligation you might have under sections 531 hot arress any obe Act for devices under the Electronic chrough 542 or the not roll provisions, or other Federal laws or requlations.

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

If you desire specific advice for your devices 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 devices, 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,

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

Enclosures

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510(k) Number: K973417

Device Name: Clinitex Stockinette

Indications For Use: Clinitex® Stockinette is a tubular textile used to form the first protective layer (base) of an orthopedic cast below the cast padding and cast tape. The polyester material help repel water and dry rapidly.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

(Divisi eneral Restorative Dev 510(k) Num

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use
(Optional Format 1-2-96)