(59 days)
Hemosorb is intended as a topical dressing for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.
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.
The provided document is a 510(k) summary for the device Hemosorb, a topical dressing for managing bleeding wounds. It addresses the device's substantial equivalence to a predicate device, Sorbastace.
Here's an analysis of the acceptance criteria and the study descriptions, organized by your requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal "acceptance criteria" in a quantitative manner as might be seen for a new, de novo device. Instead, it focuses on demonstrating "substantial equivalence" to a predicate device, Sorbastace. The performance is reported in terms of efficacy in stopping bleeding and biocompatibility.
| Acceptance Criteria (Implied) | Reported Device Performance (Hemosorb) |
|---|---|
| Efficacy in stopping bleeding | Consistently performed well above a collagen-based hemostatic agent in rate of coagulation and reduction of bleeding time in in vitro and in vivo (rat, rabbit, larger mammals) tests. |
| Superior to other hemostatic agents in ability to stop bleeding in VAMC tests on rats and pigs' livers and skin. | |
| Mortality Rate: 0% with Hemosorb + standard dressing (vs. 80% no dressing, 33.4% standard dressing only) in a large animal model of lethal uncontrolled hemorrhage (USUHS/Office of Naval Research). | |
| Lowest volume of blood loss among tested hemostatic agents in the USUHS/Office of Naval Research study. | |
| Biocompatibility (Toxicity) | Lower toxicity score in rat histopathology than other hemostatic agents (UConn Chemistry Department); only 10% higher than inert control. |
| Passed various ISO 17025 certified biocompatibility tests (Agar Overlay Cytotoxicity, Skin Sensitization, Skin Irritation, Intracutaneous Test, MEM Elution Cytotoxicity, Muscle Implant). | |
| Physical Properties | High adsorptive effect on liquid (Water Adsorption Rate test passed). |
| Similarity to predicate device (Sorbastace) | "Substantially alike in purpose, characteristic, process, and result to Sorbastace." |
2. Sample size used for the test set and the data provenance
The document provides details of several tests, but specific sample sizes for each animal study are often not explicitly stated.
- In vitro and In vivo (rats, rabbits, larger mammals) at the University of Connecticut: "In Invitro and Invivo testing on rats, rabbits and larger mammals at the University of Connecticut." No specific numbers mentioned, but indicates multiple types of animals.
- VAMC (rats and pigs): "Tests by the Chief of Surgery at VAMC. Newington, CT, conducted at Hartford Hospital on rats and pigs' livers and skin." No specific numbers mentioned.
- USUHS and Office of Naval Research (large mammals): This study clearly states a mortality rate for "No Dressing," "Standard Dressing," and "Standard Dressing with Hemosorb," implying a cohort for each. However, the exact sample size (number of large mammals) in each group is not provided.
- Biocompatibility testing (MicroTest Laboratories, Inc.): These are laboratory tests on samples of the device material, not on a "test set" of patient data.
Data Provenance: The studies were conducted in the USA (University of Connecticut, Hartford Hospital, VAMC Newington CT, USUHS, MicroTest Laboratories, Inc. of Agawam, Mass.). All studies appear to be retrospective data collected for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not detail the use of "experts" to establish a ground truth for a test set in the way a clinical study for diagnostic devices might. Instead, the "ground truth" for efficacy was based on measurable physiological outcomes (coagulation rate, bleeding time, blood loss, mortality) observed in animal models. Toxicity was assessed through histopathology and standard biocompatibility tests.
The studies were conducted by:
- University of Connecticut researchers
- UConn Chemistry Department
- Chief of Surgery at VAMC, Newington, CT (conducted at Hartford Hospital)
- USUHS (Uniformed Services University of the Health Sciences) and Office of Naval Research
- ISO 17025 Certified MicroTest Laboratories, Inc.
The qualifications mentioned are "Chief of Surgery" and "UConn Chemistry Department," which imply relevant expertise but specific years of experience or board certifications are not provided.
4. Adjudication method for the test set
Not applicable. The studies described are preclinical animal studies and laboratory tests, not clinical trials involving human readers or subjective assessments that would require an adjudication method. The outcomes measured are objective (e.g., mortality, blood loss, lab test results).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device for local management of bleeding, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI assistance comparison was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical hemostatic agent, not an algorithm. Therefore, no standalone algorithm performance was evaluated.
7. The type of ground truth used
The ground truth used was based on objective physiological measurements and standardized laboratory results:
- Efficacy: Coagulation rate, bleeding time, reduction in blood loss, and survival/mortality rates in various animal models (rats, rabbits, pigs, large mammals).
- Toxicity/Biocompatibility: Histopathology scores in rats and results from standard ISO biocompatibility tests (cytotoxicity, sensitization, irritation, implant reactions).
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based device, so there is no "training set" in that context. The development of the device would have involved iterative testing and refinement, but not in the sense of a data-driven training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an algorithm.
{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 | SorbastaceK-965034Company: Hemostace |
| Contact Person | Bart Gullong, Vice-President |
| Company Name | Z-Medica, LLC |
| Company Address | 35 Budney RoadNewington, 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 |
3
{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
N/A