K-965034
Not Found
No
The device description explicitly states its effect is "purely physical, not chemical in nature" and relies on adsorption. There is no mention of AI, ML, or any computational processing.
Yes
No
The device, Hemosorb, is described as a topical dressing and hemostatic agent for managing bleeding wounds. Its function is to stop bleeding by physically adsorbing liquid and concentrating platelets, not to diagnose any condition.
No
The device description clearly states that Hemosorb is a "bulk granular hemostatic agent," indicating it is a physical substance, 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 topical dressing for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions." This describes a device applied directly to the body to treat a physical condition (bleeding).
- Device Description: The description explains a physical mechanism of action (adsorption and coagulation) applied to a wound.
- Lack of In Vitro Testing: While there are performance studies mentioned, they focus on in vivo (on living organisms like rats, rabbits, pigs, and larger mammals) and biocompatibility testing. There is no mention of testing biological samples outside the body for diagnostic purposes.
- No Diagnostic Claims: The device is intended to manage bleeding, not to diagnose a condition.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. Hemosorb does not fit this description.
N/A
Intended Use / Indications for Use
Hemosorb is intended as a topical dressing for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.
Product codes (comma separated list FDA assigned to the subject device)
FRO, QSY
Device Description
Hemosorb is a bulk granular hemostatic agent, which is placed on or into a wound to effect adsorption, and coagulation of same.
The effect of Hemosorb is purely physical, not chemical in nature. Hemosorb has an unusually high adsorptive effect on liquid. This rapid adsorption of water as a blood component serves to concentrate platelets, and increase the speed and effect of their clotting capabilities. This rapid adsorption also diminishes the volume of the liquid present in the wound as a sponge effect, to facilitate clotting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wounds (e.g., minor cuts, lacerations, and abrasions)
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 and In vivo testing: Conducted on rats, rabbits, and larger mammals at the University of Connecticut.
- Results: Hemosorb consistently performed well above a cologen-based hemostatic agent in rate of coagulation and reduction of bleeding time.
- Toxicity Tests: Conducted by the UConn Chemistry Department.
- Results: Hemosorb showed a lower toxicity score of rat histopathology following application to stop bleeding than other hemostatic agents. Toxicity was only 10% higher than the inert control device used.
- Comparison Testing: Conducted by the Chief of Surgery at VAMC, Newington, CT, at Hartford Hospital on rats and pigs' livers and skin.
- Results: Hemosorb was found to be superior to other hemostatic agents in its ability to stop bleeding.
- Large Mammal Study: Conducted by USUHS and the Office of Naval Research in March 2002 using a large animal model of lethal uncontrolled hemorrhage. This study tested if various hemostatic agents (in addition to standard dressing) would decrease bleeding and improve early survival.
- Mortality Rate:
- No Dressing = 80%
- Standard Dressing = 33.4%
- Standard Dressing with Hemosorb = 0%
- Blood Loss: Hemosorb resulted in the lowest volume of blood loss of tested hemostatic agents.
- Mortality Rate:
- Biocompatibility testing: Completed by ISO 17025 Certified MicroTest Laboratories, Inc., of Agawam, Mass.
- Tests included: Agar Overlay Cytotoxicity Test (Sample # 02-00480, Dated 01/29/02), Water Adsorption Rate (Sample # 02-00254, Dated 01/21/02), Skin Sensitization (Sample # 01-06556, Dated 12/21/01), Skin Irritation (Sample # 01-06555, Dated 12/07/01), Intracutaneous Test (Sample # 01-06554, Dated 11/30/01), MEM Elution Cytotoxicity Test (Sample # 01-06492, Dated 11/08/01), Muscle Implant (Sample # 01-06476, Dated 01/08/01).
- Overall Summary: Hemosorb performed extremely well and is considered a safe, effective, low cost wound dressing.
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.
K-965034
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
N/A
0
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is blue and white.
On Site Gas Systems, Inc. Francis X. Hursey President 35 Budney Road Newington, Connecticut 06111 June 11, 2023
Re: K021581 Trade/Device Name: Hemosorb Regulatory Class: Unclassified Product Code: QSY
Dear Francis X. Hursey:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 12, 2002. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSY.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.
Image /page/0/Picture/7 description: The image shows the closing of a letter, including the signature of Julie A. Morabito, Ph.D., who is the Assistant Director. The letter is from DHT4B: Division of Infection Control and Plastic Surgery Devices. It also mentions OHT4: Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality, and the Center for Devices and Radiological Health.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, and they are connected by a flowing line that suggests movement and unity.
JUL 12 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Francis X. Hursey President On Site Gas Systems, Inc. 35 Budney Road Newington, Connecticut 06111
Re: K021581
Trade/Device Name: Hemosorb Regulatory Class: Unclassified Product Code: FRO Dated: May 9, 2002 Received: May 14, 2002
Dear Mr. Hursey:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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); 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.
2
Page 2 - Mr. Francis X. Hursey
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Aztyt Rlwdn
Celia M! Witten, Ph.D., M.D.
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
STATEMENT OF INDICATIONS FOR USE
Hemosorb is intended as a topical dressing for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.
Stupt Rurdia
(Division Sign-Off) Division of General, Restorative and Neurological Devices
K021581 510(k) Number --
4
'JUL 12 2002
. 17. s
page 1 of 4
510(k) Summary
Z-MEDICA, LLC 35 BUDNEY ROAD
NEWINGTON, CT 06111 860.667.8888
CONTACT PERSON
BART GULLONG VICE-PRESIDENT
REVISED: JUNE 28, 2002
4-1 Revised 6/28/02
5
K021581
page 2 of 4
2
510(k) Summary
| Trade Name | Hemosorb |
|---|---|
| Device Class | Unclassified |
| Classification Panel | General and Plastic Surgery |
| Common Name | Traumatic Wound Dressing |
| Predicate Device | Sorbastace |
| K-965034 | |
| Company: Hemostace | |
| Contact Person | Bart Gullong, Vice-President |
| Company Name | Z-Medica, LLC |
| Company Address | 35 Budney Road |
| Newington, CT 06111 | |
| Company Phone # | 860.667.2201 |
| Revised | June 28, 2002 |
Statement of Indications for Use
Hemosorb is intended as a topical dressing for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.
Device Description
Hemosorb is a bulk granular hemostatic agent, which is placed on or into a wound to effect adsorption, and coagulation of same.
The effect of Hemosorb is purely physical, not chemical in nature. Hemosorb has an unusually high adsorptive effect on liquid. This rapid adsorption of water as a blood component serves to concentrate platelets, and increase the speed and effect of their clotting capabilities. This rapid adsorption also diminishes the volume of the liquid present in the wound as a sponge effect, to facilitate clotting.
4-2 Revised 6/28/02
6
The product is designed and packaged to be easily packed, carried and applied using only one hand. It is well suited for wounds, to create hemostasis by coagulation.
Hemosorb has been tested in-house at On Site, at Hartford Hospital, by Johnson & Johnson, and at the University of Connecticut by Micro Test Laboratories, and at USUHS for the military. Testing and results are enclosed.
In Invitro and Invivo testing on rats, rabbits and larger mammals at the University of Connecticut. Hemosorb consistently performed well above a cologen-based hemostatic agent in rate of coagulation and reduction of bleeding time.
Tests of Hemosorb by the UConn Chemistry Department showed a lower toxicity score of rat histopathology following application of compound to stop bleeding than other hemostatic agents. Toxicity was only 10% higher than the inert control device used.
Tests by the Chief of Surgery at VAMC. Newington, CT, conducted at Hartford Hospital on rats and pigs' livers and skin, found Hemosorb was superior to other hemostatic agents in its ability to stop bleeding.
During March 2002, testing on large mammals (animals) was completed. USUHS and the Office of Naval Research developed a large animal model of lethal uncontrolled hemorrhage. This was used to test whether the use of various hemostatic agents (in addition to standard dressing) would decrease bleeding and improve early survival. The study was highly controlled. The following is a brief summary of Hemosorb's successful results:
| Mortality Rate: No Dressing = 80% | |
|---|---|
| Standard Dressing = 33.4% | |
| Standard Dressing with Hemosorb = 0% | |
| Blood Loss | Hemosorb = lowest volume of blood loss |
| of tested hemostatic agents. |
Biocompatibility testing was completed by ISO 17025 Certified MicroTest Laboratories, Inc., of Agawam, Mass. The tests included:
| Test | Sample # | Dated |
|---|---|---|
| Agar Overlay Cytotoxicity Test | 02-00480 | 01/29/02 |
| Water Adsorption Rate | 02-00254 | 01/21/02 |
| Skin Sensitization | 01-06556 | 12/21/01 |
| Skin Irritation | 01-06555 | 12/07/01 |
| Intracutaneous Test | 01-06554 | 11/30/01 |
| MEM Elution Cytotoxicity Test | 01-06492 | 11/08/01 |
| Muscle Implant | 01-06476 | 01/08/01 |
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7
page 4 of 4
4
In summary, Hemosorb performed extremely well.
Hemosorb is a safe, effective, low cost wound dressing which is substantially alike in purpose, characteristic, process, and result to Sorbastace, and thereby eligible for approval under 510(k).
4-4 Revised 6/28/02