(151 days)
Vascette HP is intended for use as a temporary topical dressing for the management of bleeding from vascular access sites and percutaneous catheters.
Vascette HP is a 2 inch x 2 inch (50mm x 50mm) square, single use, multi-layer temporary topical wound dressing applied over vascular puncture sites and percutaneous catheter sites. There are two tissue contacting components in the device: 1) the polyethylene adhesive foam border and 2) the plant derived modified starch (carboxyl starch sodium (CMS)) hemostatic foam. The hemostatic foam is hydrophilic and dehydrates blood at the wound site, producing hemostasis. The device is non-invasive, and removal protocol is the same as other temporary topical hemostatic pads. Sterilization of the device is performed utilizing gamma irradiation to SAL 10-6.
Here is a summary of the acceptance criteria and the study details for the Vascette HP device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Achieved hemostasis | Achieved hemostasis within 5 minutes and 45 seconds in all test animals. |
| No clinically significant gross pathology findings related to the device | No clinically significant findings on gross pathology related to the subject device. |
| Non-cytotoxic | Non-cytotoxic (ISO 10993-5) |
| Non-toxic (Sensitization) | Non-toxic (ISO 10993-10) |
| Non-toxic (Intracutaneous Reactivity) | Non-toxic (ISO 10993-10) |
| Non-toxic (Acute Systemic Toxicity) | Non-toxic (ISO 10993-11) |
| Non-pyrogenic | Non-pyrogenic (ISO 10993-11) |
| Sterilization Assurance Level (SAL) 10-6 achieved | SAL 10-6 achieved (ISO 11137-2) |
| Bubble Leak Test Pass | Pass (ASTM F2096-11) |
| Seal Strength Test Pass | Pass (ASTM F88) |
| Distribution Simulation Pass | Pass (ASTM 4196-16) |
| Six Month Accelerated Aging Pass | Pass (ASTM 1980-16) |
| Two Year Accelerated Aging Pass | Pass (ASTM 1980-16) |
| Substantial equivalence to predicate device in safety and effectiveness | Confirmed substantial equivalence with respect to safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states that hemostasis was achieved "in all test animals" in the porcine model study. However, the exact number of animals used in the GLP and non-GLP studies is not specified in the provided text.
- Data Provenance: The animal study was conducted using a porcine (pig) model. The country of origin for the data is not explicitly stated. The study type was pre-clinical animal evaluation, conducted according to GLP regulations (21 CFR Part 58), and would be considered prospective for the animal model.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
The document does not mention the use of human experts to establish ground truth for the test set. The outcome of hemostasis and gross pathology findings would have been evaluated by veterinary professionals involved in the animal study. Specific qualifications of these individuals are not provided.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. The assessment of hemostasis and gross pathology would have been part of the standard protocol for the animal study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The document explicitly states: "Evaluation in a clinical setting has not been performed." This implies no human-in-the-loop studies were conducted comparing AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study
The device is a topical hemostatic pad, not an algorithm. Therefore, the concept of an "algorithm only" or "standalone" performance study in the context of AI does not apply to this medical device. The performance was assessed through the animal study and bench testing.
7. Type of Ground Truth Used
The ground truth for the primary performance claim (hemostasis) was established by direct observation and measurement in a porcine animal model. For biocompatibility and sterilization, the ground truth was based on the outcomes of standardized laboratory tests. For the animal study, it included:
- Observation of hemostasis achievement.
- Gross pathology findings.
- Veterinary assessments (physical examination, body condition score, body weight, clinical monitoring, clinical pathology).
8. Sample Size for the Training Set
The document does not mention a training set in the context of an algorithm or AI. The Vascette HP is a physical medical device, not a software algorithm that would require training data.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an algorithm, this question is not applicable.
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July 29, 2022
Koag LLC David Lang Chief Executive Officer 790 Rarity Bay Pkwy Vonore, Tennessee 37885
Re: K220566
Trade/Device Name: Vascette VCD Regulatory Class: Unclassified Product Code: FRO Dated: April 1, 2022 Received: April 4, 2022
Dear David Lang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Julie Morabito, Ph.D. Assistant Director 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
Enclosure
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Indications for Use
510(k) Number (if known) K220566
Device Name Vascette HP
Indications for Use (Describe)
Vascette HP is intended for use as a temporary topical dressing for the management of bleeding from vascular access sites and percutaneous catheters.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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6. 510(k) SUMMARY (AS REQUIRED BY 21 CFR §807.92(c))
510(k) Owner Information:
KOAG International, LLC 790 Rarity Bay Parkway Vonore, TN 37885 Contact person: David Lang Phone: 470-755-9291 Email: dlang@koag.life Date of Preparation: February 25, 2022
Device Information:
| Proprietary name: | Vascette® HP, Topical Hemostatic Pad |
|---|---|
| Regulation Class.: | Unclassified |
| Classification name: | Dressing, Wound, Drug |
| Product Code: | FRO |
SoftSeal®-STF (K090100) Predicate Device:
Description of the Device:
Vascette HP is a 2 inch x 2 inch (50mm x 50mm) square, single use, multi-layer temporary topical wound dressing applied over vascular puncture sites and percutaneous catheter sites. There are two tissue contacting components in the device: 1) the polyethylene adhesive foam border and 2) the plant derived modified starch (carboxyl starch sodium (CMS)) hemostatic foam. The hemostatic foam is hydrophilic and dehydrates blood at the wound site, producing hemostasis. The device is non-invasive, and removal protocol is the same as other temporary topical hemostatic pads. Sterilization of the device is performed utilizing gamma irradiation to SAL 10-6.
Intended Use:
Vascette HP is intended for use as a temporary topical dressing for the management of bleeding from vascular access sites and percutaneous catheters. The device is to be used under the care of a health care professional.
Summary of Technical Characteristics Compare to the Predicate Device:
Comparison of the technological characteristics of the subject device. Vascette HP, and predicate device, SoftSeal®-STF, show that the two devices are similar in dimensional design, pH, and intended use as topical hemostatic pads. Both devices have similar packaging and gamma irradiation sterilization methodology.
The primary difference between the subject and predicate devices is the composition of hemostatic agents. Vascette HP contains plant-based polysaccharide foam hemostatic material while SoftSeal-STF contains animal-based, non-woven chitosan fibers.
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Nonclinical Test Submitted: Animal Study
A porcine model was utilized in both the GLP and non-GLP studies. Veterinary assessments inclusive of physical examination, body condition score, body weight, clinical monitoring and clinical pathology suggested that the animal was clinically healthy at study enrollment. A pre-clinical animal GLP evaluation was conducted according to applicable regulations, 21 CFR Part 58, Good Laboratory Practices Regulations, to assess the achievement of hemostasis in percutaneous arterial access sites.
The subject device, Vascette HP, achieved hemostasis within five (5) minutes and fortyfive (45) seconds in all test animals. In addition, there were no clinically significant findings on gross pathology that were deemed related to the subject device.
Nonclinical Test Submitted: Performance Testing
Bench performance testing of the Vascette HP consisted of visual inspection, dimensional measurements, liner peel testing and material certifications. Test results confirmed Vascette HP is substantially equivalent to the predicate device with respect to safety and effectiveness.
Additional Nonclinical Performance Testing that was conducted consists of the following:
| Biocompatibility Test | Standard Followed | Outcome |
|---|---|---|
| Cytotoxicity | ISO 10993-5 | Non-cytotoxic |
| Maximum Sensitization | ISO 10993-10 | Non-toxic |
| Intracutaneous Reactivity | ISO 10993-10 | Non-toxic |
| Acute Systemic Toxicity | ISO 10993-11 | Non-toxic |
| Pyrogenicity | ISO 10993-11 | Non-pyrogenic |
| Sterilization and Packaging | Standard Followed | Outcome |
|---|---|---|
| Sterilization Validation | ISO 11137-2 | SAL 10-6 achieved |
| Bubble Leak Testing | ASTM F2096-11 | Pass |
| Seal Strength Test | ASTM F88 | Pass |
| Distribution Simulation | ASTM 4196-16 | Pass |
| Six Month Accelerated Aging | ASTM 1980-16 | Pass |
| Two Year Accelerated Aging | ASTM 1980-16 | Pass |
Clinical Tests Submitted:
Evaluation in a clinical setting has not been performed.
Conclusions:
The Vascette HP is substantially equivalent to the predicate device with respect to intended use, Indications for Use, design, sterilization, and biocompatibility. The non-clinical testing data provided support the substantial equivalence of the device to the predicate device. Therefore, any minor differences between the subject device and the predicate do not raise any different safety or effectiveness issues with the subject device.
N/A