(232 days)
InnoSEAL Hemostatic Pad is intended for the local management of bleeding wounds and for the promotion of rapid control of bleeding. InnoSEAL Hemostatic Pad is intended for use under the care of a healthcare professional.
The dressing is indicated for following wounds; lacerations, abrasions and the skin surface puncture sites for vascular procedures, percutaneous catheters/tubes.
InnoSEAL Hemostatic Pad is a hydrophilic, lyophilized sponge pad for local management of bleeding wound made of proprietary formulation of chitosan and catechol conjugated chitosan which are biocompatible. InnoSEAL Hemostatic Pad is applied topically as an adjunct to manual compression. InnoSEAL Hemostatic Pad is a single use device individually packaged by PET mold and Aluminum lid and sterilized with gamma irradiation.
The provided text describes the InnoSEAL Hemostatic Pad and its substantial equivalence determination, but it does not contain a specific table or study explicitly detailing acceptance criteria and reported device performance for a typical AI/ML medical device submission.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through various performance tests, rather than setting and meeting specific quantitative acceptance criteria for a novel AI/ML algorithm.
Therefore, I cannot provide a direct answer to the request based on the provided text, as the necessary information (acceptance criteria table, study proving device meets criteria, sample sizes for test/training sets of an AI model, expert ground truth details, MRMC study, standalone performance, etc.) is not present for an AI/ML device.
However, I can extract information about the performance data provided for the InnoSEAL Hemostatic Pad and summarize what is available:
Summary of Performance Data for InnoSEAL Hemostatic Pad (as presented in the document):
The submission for the InnoSEAL Hemostatic Pad does not present performance data in the typical format of acceptance criteria and reported performance for an AI/ML device. Instead, it relies on a series of tests to demonstrate equivalence to predicate devices. The studies mentioned are primarily pre-clinical (bench and animal) rather than clinical efficacy trials with human subjects.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not Applicable / Not Present. The document does not define specific "acceptance criteria" (e.g., minimum sensitivity, specificity, or AUC) that an AI/ML model would typically need to meet, nor does it present device performance against such criteria. The submission is for a physical medical device (hemostatic pad), not an AI/ML algorithm.
2. Sample Sizes Used for the Test Set and Data Provenance:
- Test Set (Animal Study): "In-vivo hemostasis test using swine femoral artery hemorrhage model was performed to demonstrate the effectiveness and safety of InnoSEAL Hemostatic Pad."
- Sample Size: Not explicitly stated, though it refers to "Study 15-KE-136." The number of swine or specific arteries tested is not provided.
- Data Provenance: Animal study (swine model), likely prospective within the context of the study. Country of origin not specified, but the submitter is InnoTherapy Inc. from Seoul, Republic of Korea.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not applicable. For the animal study, "Gross necropsy and histopathological evaluations" were performed. The "ground truth" here would likely be determined by veterinary pathologists or researchers involved in the animal model. The number and qualifications of these experts are not provided.
4. Adjudication Method for the Test Set:
- Not explicitly stated. For the animal study, it mentions "Gross necropsy and histopathological evaluations," suggesting standard veterinary pathology practices were followed. No specific adjudication method like "2+1" or "3+1" is mentioned, as this is typically for human reader studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This type of study is specifically for evaluating human readers, often with and without AI assistance, and is not relevant to the evaluation of a physical hemostatic pad.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a physical pad, not an algorithm.
7. The Type of Ground Truth Used:
- Animal Outcomes/Histopathology/Gross Necropsy: For the animal study, the effectiveness and safety were assessed through observations of hemostasis, and subsequent gross and histopathological evaluations of tissues.
8. The Sample Size for the Training Set:
- Not applicable. As this is not an AI/ML device, there is no "training set."
9. How the Ground Truth for the Training Set was Established:
- Not applicable. There is no training set for a physical hemostatic pad.
Summary of Other Performance Data (Bench Tests):
The document also lists several bench tests conducted to demonstrate the device's characteristics and safety:
- Biocompatibility tests: Acute systemic toxicity, Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Endotoxin. (Results "met all relevant requirements.")
- Comparative liquid absorption test: (Results: "equivalent to predicate device.")
- Identification tests: Comparative FT-IR analysis, Gelation test.
- Physical/Chemical tests: Appearance, Residue on ignition, Degree of oxidation, Loss on drying, Heavy metal, pH, Residual solvent, Deacetylation degree.
- Packaging tests: Qualification, Burst, Tensile/Tearing/Heat-sealing strength, Dye penetration.
- Sterility and Shelf life tests: Sterilization validation, Accelerated stability, Real-time stability.
- Microbiological safety tests: Virus clearance tests (demonstrated "efficient virus inactivation").
These tests are designed to show that the InnoSEAL Hemostatic Pad is safe, performs as expected technologically, and is substantially equivalent to existing, legally marketed predicate devices. The "acceptance criteria" for these tests would be the specific standards and limits defined in the respective test protocols and relevant consensus standards. The "reported performance" is that the device "met all relevant requirements" or was "equivalent to predicate device." However, specific numerical acceptance criteria and performance metrics for each of these diverse tests are not tabulated in the provided text.
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April 21, 2023
InnoTherapy Inc. % Robert Schiff, Ph.D., RAC, CQA, FRAPS Schiff & Company, Inc. 1120 Bloomfield Ave. West Caldwell, New Jersey 07282
Re: K161013 Trade/Device Name: InnoSEAL Hemostatic Pad Regulatory Class: Unclassified Product Code: QSY
Dear Dr. Robert Schiff:
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 November 29, 2016. 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 a letter closing with the name Julie A. Morabito. The next line shows Julie Morabito, Ph.D., followed by Assistant Director. The last line shows DHT4B: Division of Infection Control.
and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 29, 2016
InnoTherapy, Inc. Robert Schiff, Ph.D., RAC, CQA, FRAPS Schiff & Company, Inc. 1120 Bloomfield Ave. West Caldwell, NJ 07006
Re: K161013
Trade/Device Name: InnoSEAL Hemostatic Pad Regulatory Class: Class: Unclassified Product Code: FRO Dated: October 31, 2016 Received: November 1, 2016
Dear Dr. Schiff:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161013
Device Name
InnoSEAL Hemostatic Pad
Indications for Use (Describe)
InnoSEAL Hemostatic Pad is intended for the local management of bleeding wounds and for the promotion of rapid control of bleeding. InnoSEAL Hemostatic Pad is intended for use under the care of a healthcare professional.
The dressing is indicated for following wounds; lacerations and the skin surface puncture sites for vascular procedures, percutaneous catheters/tubes.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
(1) SUBMITTER:
InnoTherapy Inc. Ace Hightechcity2, 25, Seonyu-ro 13-gil, Yeongdeungpo-gu, Seoul, 07282 Republic of Korea Telephone : +82 (2) 6959 1338 Contact person : Moon Sue Lee, CEO Date prepared : October 31, 2016
(2) DEVICE NAME: InnoSEAL Hemostatic Pad Trade Name: InnoSEAL Hemostatic Pad Common Name: Topical Hemostasis Pad Classification Name: Topical Wound Dressing Pad Device Class: Unclassified Product Code: FRO
- (3) PREDICATE DEVICE: Substantial equivalence is based on following legally marketed devices.
The predicates have not been subject to a design-related recall. No reference devices were used in this submission.
- (4) DESCRIPTION OF THE DEVICE: InnoSEAL Hemostatic Pad is a hydrophilic, lyophilized sponge pad for local management of bleeding wound made of proprietary formulation of chitosan and catechol conjugated chitosan which are biocompatible. InnoSEAL Hemostatic Pad is applied topically as an adjunct to manual compression. InnoSEAL Hemostatic Pad is a single use device individually packaged by PET mold and Aluminum lid and sterilized with gamma irradiation.
- (5) INTENDED USE: InnoSEAL Hemostatic Pad is intended for the local management of bleeding wounds and for the promotion of rapid control of bleeding. InnoSEAL Hemostatic Pad is intended for use under the care of a healthcare professional.
The dressing is indicated for following wounds; lacerations, abrasions and the skin surface puncture sites for vascular procedures, percutaneous catheters/tubes.
InnoSEAL Hemostatic Pad has essentially the same intended use as the predicate device.
- (6) TECHNOLOGICAL CHARACTERISTICS: InnoSEAL Hemostatic Pad is made of proprietary formulation of chitosan and catechol conjugated chitosan and is comprised of massively porous sponge. InnoSEAL Hemostatic Pad achieves the principal intended action of hemostasis by providing a physical barrier and effective
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510(K) Premarket Notification for InnoSEAL Hemostatic Pad InnoTherapy Inc.
blood absorption to stop bleeding. Chitosan is a naturally occurring polysaccharide derived from shellfish. The natural biological property of chitosan caries cation (positively charged ion) that helps to stop external hemorthage. In addition, catechol conjugated chitosan aids hemostasis by coating surface of bleeding area and forming a physical barrier enabling prompt control of bleeding and protection against foreign element contamination.
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- (7) COMPARISON WITH PREDICATE DEVICES: Following table is a comparison of our new InnoSEAL Hemostatic Pad and predicate devices.
| InnoSEAL HemostaticPad | Predicate 1Clo-Sur Plus P.A.D.(K032986) | Predicate 2Hemo-Pad (K102944) | |
|---|---|---|---|
| Product Code | FRO | FRO | FRO |
| Prescription /OTC | Prescription | Prescription | Prescription |
| PhysicalComposition | a hydrophilic, lyophilizedsponge pad made ofproprietary formulation ofchitosan and catecholconjugated chitosan | a soft, non-woven padmade of a proprietaryformulation ofpoly-D-glucosamine andpoly-N-acetylglucosaminederived from chitosan. | a soft, non-woven topicalpad made ofpoly-D-glucosamine andpoly-N-acetylglucosaminederived from chitosan. |
| Intended Use | Local management ofbleeding wounds and forthe promotion of rapidcontrol of bleeding.The dressing is indicatedfor following wounds;Lacerations, Abrasions andthe skin surface puncturesites for vascularprocedures, percutaneouscatheters/tubes. | Local management ofbleeding wounds and toprovide a barrier tobacterial penetration of thedressing in all patients andfor the promotion of rapidcontrol (hemostasis) ofbleeding in patientsfollowing hemodialysis andfor those on anticoagulationtherapy.The dressing is indicatedfor the following wounds:lacerations, abrasions, nosebleeds, and the skin surfacepuncture sites for vascularprocedures, percutaneouscatheters or tubes. | topical wound managementand for the external topicaltemporary control ofmoderate to severebleeding.The dressing is indicatedfor the following wounds:abrasions, lacerations, skinsurface puncture sites forvascular procedures(arteriesand veins) |
| Single Use Only | Yes | Yes | Yes |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible |
| SterilizationMethod andLevel | sterilized by gamma-rayradiation to a 106 SAL. | sterilized by E-beamradiation to a 106 SAL. | sterilized by gamma-rayradiation to a 106 SAL. |
Use of chitosan as a hemostatic agent for the control of bleeding is the technical principle for both the subject and predicate devices. (K032986, K102944) It is based on the natural biological property of chitosan that carries cation (positively charged ion) that helps to stop external hemorrhage.
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At a high level, the subject and predicate devices are based on the following same technological elements:
- . Chitosan - used as a hemostatic agent
- Device applied topically as an adjunct to manual compression
- Topical pad to absorb blood and wound exudates ●
The following technological differences exist between the subject and predicate devices:
-
Use of catechol conjugated chitosan
InnoSEAL Hemostatic Pad has small quantity of catechol conjugated chitosan while predicate devices do not have. This slight difference is insignificant and does not affect the intended use and performance of the device. InnoSEAL Hemostatic Pad and its predicate devices are made from similar materials, utilize the same hemostatic mechanism, and have similar intended use. -
PERFORMANCE DATA: The following performance data has been provided in support of the (8) substantial equivalence determination.
Biocompatibility tests
Biocompatibility tests were conducted following procedures outlined in the respective consensus standards, and results for InnoSEAL Hemostatic Pad met all relevant requirements in the test standards. The battery of testing included the following tests:
- Acute systemic toxicity ●
- Cytotoxicity
- Skin Sensitization ●
- Intracutaneous Reactivity
- Endotoxin
The intended use of the InnoSEAL Hemostatic Pad puts it within the biocompatibility category of limited contact duration, and breached/compromised surface device.
Comparative liquid absorption test
Liquid absorption test was conducted on the InnoSEAL Hemostatic Pad and the predicate device. Both hemostatic pads presented fast liquid absorption rates and liquid absorption capability of InnoSEAL Hemostatic Pad was equivalent to predicate device.
Identification tests
- Comparative FT-IR analysis of chitosan and InnoSEAL Hemostatic Pad ●
- Gelation test
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Physical/Chemical tests
- Appearance
- . Residue on ignition
- Degree of oxidation ●
- Loss on drying ●
- Heavy metal ●
- pH
- Residual solvent ●
- Deacetylation degree ●
Packaging tests
- Qualification test and evaluation of blister packaging machine ●
- Burst test ●
- Tensile / Tearing / Heat-sealing strength test
- Dye penetration test
Sterility and Shelf life tests
- Sterilization validation test
- Accelerated stability test ●
- Real-time stability test ●
Microbiological safety tests
Virus clearance tests were conducted to support adequacy of virus inactivation during the manufacture of InnoSEAL Hemostatic Pad. The studies demonstrated that efficient virus inactivation manufacturing steps are included with complete inactivation result of model viruses.
Animal tests
In-vivo hemostasis test using swine femoral artery hemorrhage model was performed to demonstrate the effectiveness and safety of InnoSEAL Hemostatic Pad. In study 15-KE-136. InnoSEAL Hemostatic Pad and predicate device showed superior hemostatic efficacy compared to manual compression with regular gauze. Gross necropsy and histopathological evaluations were similar and comparable between the groups. In overall, InnoSEAL Hemostatic Pad was effective and shortened the time to hemostasis at injured femoral artery access sites. InnoSEAL Hemostatic Pad was safe and effective for its intended use.
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The collective results of the bench and animal testing demonstrate that the materials chosen, the manufacturing process, and the design of the InnoSEAL Hemostatic Pad meet the established specifications necessary for the consistent performance during its intended use. In addition, the tests demonstrate that the InnoSEAL Hemostatic Pad does not raise new questions of effectiveness or safety for its intended use when compared to the predicate devices.
- (9) CONCLUSION: Based on the comparison of intended use, design, materials, and performance, InnoSEAL Hemostatic Pad is substantially equivalent to legally marketed predicate devices and is safe and effective for its intended use.
N/A