(151 days)
SoftSeal®-STF (K090100)
Not Found
No
The device description focuses on the physical and chemical properties of the dressing for hemostasis, with no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as a temporary topical dressing for managing bleeding, which falls under wound dressing/hemostatic devices rather than a therapeutic device for treating a disease or condition in the body.
No
Explanation: The device is described as a temporary topical dressing for managing bleeding, with its primary function being hemostasis (stopping bleeding) through a physical mechanism (dehydrating blood). Its intended use and description do not mention any diagnostic capabilities, such as measuring, analyzing, or identifying medical conditions.
No
The device description clearly outlines physical components (polyethylene adhesive foam border, plant derived modified starch hemostatic foam) and a sterilization process (gamma irradiation), indicating it is a physical medical device, not software-only.
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 temporary topical dressing for the management of bleeding from vascular access sites and percutaneous catheters." This describes a device applied externally to the body to manage bleeding, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details a topical wound dressing with hemostatic properties. It acts on the blood at the wound site externally.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are designed to examine specimens derived from the human body 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
Vascette HP is intended for use as a temporary topical dressing for the management of bleeding from vascular access sites and percutaneous catheters.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular access sites and percutaneous catheters
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The device is to be used under the care of a health care professional.
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)
Animal Study: A porcine model was utilized in both the GLP and non-GLP studies. 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.
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.
Biocompatibility Test:
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:
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
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.
SoftSeal®-STF (K090100)
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 the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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.
4
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.