HOSPAL TIPSTOP

K982818 · Gambro Healthcare · KMF · Oct 21, 1998 · General Hospital

Device Facts

• Record ID: K982818
• Device Name: HOSPAL TIPSTOP
• Applicant: Gambro Healthcare
• Product Code: KMF · General Hospital
• Decision Date: Oct 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

TIPSTOP is intended to be used as a sterile compression dressing for puncture of the vascular access site.

Device Story

Hospal TIPSTOP is a sterile compression dressing designed to stop bleeding following venipuncture. The device consists of a polyamide compressive element covered with lyophilized alginate, mounted on an adhesive film. It functions by providing mechanical compression to the vascular access site, supplementing manual compression. The device is intended for use by healthcare professionals in clinical settings. It is sterilized via gamma irradiation. The primary benefit is the mechanical management of post-venipuncture bleeding.

Clinical Evidence

No clinical data. Substantial equivalence supported by in vitro biocompatibility testing of the lyophilized alginate material.

Technological Characteristics

Polyamide compressive element with lyophilized alginate; adhesive film backing. Sterilized by gamma irradiation. Mechanical compression principle.

Indications for Use

Indicated for use as a sterile compression dressing for puncture of the vascular access site.

Regulatory Classification

Identification

A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.

Predicate Devices

• Hospal TIPSTOP (K896068)

Submission Summary (Full Text)

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KG82818

510K Notification Hospal Tipstop August 5th, , 1998

OCT 2 1 1998 510K(k) SUMMARY SUBMITTER: Gambro Healthcare 1185 Oak Street Lakewood, CO 80215 [phone] August 5th , 1998 DATE PREPARED: DEVICE NAME: Hospal TIPSTOP CLASSIFICATION NAMES: Compression Dressing Containing Alginate PREDICATE DEVICE: Hospal TIPSTOP Device Description:

# Hospal TIPSTOP

The Hospal TIPSTOP is a compressive dressing made of polyamide compressive element covered with alginate, which is placed on an adhesive film. TIPSTOP has been specially designed to stop bleeding after venipuncture in a manner similar to other compression dressings. The action mechanism consists of prolonging the manual compression with a mechanical compression carried out by the compressive element. TIPSTOP is sterilized by gamma irradiation. TIPSTOP is intended to be used as a sterile compression dressing for puncture of the vascular access site.

### Predicate Devices:

The Hospal TIPSTOP presented in this 510(k) Notification is identical in indications for use, labeling and materials to the previously cleared Hospal TIPSTOP which was cleared by the FDA on September 10th, 1990 (K896068) with one exception. The material on the compression body has been changed from lyophilized bovine collagen to lyophilized alginate.

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## Intended Use:

TIPSTOP is intended to be used as a sterile compression dressing for puncture of the vascular access site.

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This indication statement is essentially the same as the indication statement for the predicate device.

#### Technological Characteristics:

Comparing the proposed device to the predicate device, the only difference between the two devices is that the proposed device utilizes lyophilized alginate molded on to the polyamide compressive element whereas the predicate device uses lyophilized bovine collagen. This is the only significant difference.

#### Summary of Non-Clinical Tests:

In vitro testing was performed on the Hospal TIPSTOP to determine the biocompatibility characteristics of the lyophilized alginate. The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters.

#### Clinical Test Results:

Clinical testing was not performed

### Conclusions:

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Testing performed on the Hospal TIPSTOP indicates that they are safe, effective, and perform as well as the predicate device, when used in accordance with the instructions for use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 21 1998

Jeffrey R. Shideman, Ph.D. Gambro HealthCare 1185 Oak Street Lakewood, Colorado 80215-4498

Re: K982818 Trade Name: HOSPAL TIPSTOP Regulatory Class: Unclassified Product Code: KMF Dated: August 05, 1998 Received: August 11, 1998

Dear Dr. Shideman:

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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food. Drug, and Cosmetic Act (Act) and the following limitations:

- This device may not be labeled for use on third degree burns. 1.
- This device may not be labeled as having any accelerating effect on the rate of 2. wound healing or epithelization.
- This device may not be labeled as a long-term, permanent, or no-change dressing, or 3. as an artificial (synthetic) skin.
- This device may not be labeled as a treatment or a cure for any type of wound. 4.

The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).

The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against

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Page 2 - Dr. Jeffrey Shideman

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 (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) 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.

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 301-443-6597 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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510(k) NUMBER (IF KNOWN) : KOG2818 K982318 DEVICE NAME: Hospal TIPSTOP !
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INDICATIONS FOR USE:

TIPSTOP is intended to be used as a sterile compression dressing for puncture of the vascular access site.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH. Office of Device Evaluation (ODE) Prescription Use OR Over - The - Counter - Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

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