(71 days)
Not Found
No
The description focuses on mechanical compression and material properties, with no mention of AI/ML terms or functionalities.
No.
The device is a sterile compression dressing used to stop bleeding, which is a mechanical function and does not involve therapeutic action on the body's systems.
No
Explanation: The device is described as a sterile compression dressing used to stop bleeding after venipuncture, not to diagnose a condition or disease.
No
The device description clearly states it is a physical dressing made of polyamide, alginate, and adhesive film, and is sterilized by gamma irradiation. This indicates it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a sterile compression dressing for puncture of the vascular access site." This describes a device used externally on the body to apply pressure and stop bleeding.
- Device Description: The description details a physical dressing with a compressive element and adhesive film. It explains a mechanical action mechanism (prolonging manual compression).
- Lack of In Vitro Testing for Diagnostic Purposes: While there is mention of "in vitro testing" for biocompatibility, this is not the same as testing biological samples (like blood, urine, or tissue) to diagnose a condition or provide information about a patient's health status.
- No Mention of Analyzing Biological Samples: The description does not indicate that the device interacts with or analyzes any biological samples from the patient.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
TIPSTOP is intended to be used as a sterile compression dressing for puncture of the vascular access site.
Product codes (comma separated list FDA assigned to the subject device)
KMF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular access site
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 testing was not performed. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5090 Liquid bandage.
(a)
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.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
0
KG82818
510K Notification Hospal Tipstop August 5th, , 1998
OCT 2 1 1998 510K(k) SUMMARY SUBMITTER: Gambro Healthcare 1185 Oak Street Lakewood, CO 80215 (303) 231-4436 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.
in the first of the first of the first of the first of the first of the first of the first of the first for the first for the first for the first for the first for the first
Intended Use:
TIPSTOP is intended to be used as a sterile compression dressing for puncture of the vascular access site.
58:58
00000000
1
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:
} )
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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.
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
3
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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 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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