(269 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of the polysaccharide granules and their mechanism of action in promoting clotting, with no mention of AI or ML.
Yes
The device is intended for the temporary treatment of mildly bleeding wounds and for the control of bleeding, which constitutes a therapeutic use.
No
This device is not a diagnostic device. Its intended use is for the temporary treatment of bleeding wounds (therapeutic), and its mechanism of action involves forming a gelled matrix to promote clotting, not to diagnose a condition.
No
The device description clearly states it is composed of absorbable polysaccharide granules and delivery applicators, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that PerClot Topical is a "topical dressing for the temporary treatment of mildly bleeding wounds." It is applied directly to the wound to control bleeding.
- Device Description: The description explains that the granules absorb water and form a physical barrier to promote clotting. This is a mechanical and physiological action on the wound itself.
- Lack of In Vitro Testing: The description and performance studies focus on the physical properties of the granules and their ability to control bleeding topically. There is no mention of testing biological samples (like blood, urine, etc.) outside of the body to diagnose a condition or provide information about a physiological state.
IVD devices are designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. PerClot Topical is applied in vivo (on the body) to treat a physical condition (bleeding).
N/A
Intended Use / Indications for Use
PerClot Topical is intended for use under the care of a health care professional as a topical dressing for the temporary treatment of mildly bleeding wounds such as surgical wounds (postoperative, donor sites, dermatological), cuts and lacerations and for the treatment of mild bleeding from topical ENT surgical wounds and nosebleeds. It is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access, and percutaneous catheter access sites.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
PerClot® Topical is a medical device composed of absorbable polysaccharide granules and delivery applicators. The granules are biocompatible, non-pyrogenic and derived from purified potato starch. The granules do not contain any human or animal components. PerClot granules have a molecular structure that rapidly absorbs water, forming a gelled adhesive matrix that provides a mechanical barrier to further bleeding and results in the concentration of platelets, red blood cells, and coagulation proteins (thrombin, fibrinogen, etc.) at the site of application. The gelled adhesive matrix thus promotes the normal physiological clotting cascade. PerClot granules are enzymatically degraded by alpha-amylase and glucoamylase and by macrophages.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wounds (surgical, donor sites, dermatological), cuts and lacerations, topical ENT surgical wounds, nosebleeds, skin at percutaneous needle access, vascular access, and percutaneous catheter access sites.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Bench Testing: Functional testing demonstrated that PerClot is substantially equivalent when compared to the predicate device.
Performance Testing: Studies demonstrated that PerClot meets the total water absorption, rate of water absorption, adhesion/cohesion, and particle/granule size distribution specifications. The function of the product is directly related to these performance specifications. A Pre-clinical GLP evaluation was conducted according to applicable standards. This study supports PerClot's is safety and effectiveness.
Clinical Testing: Evaluation in a clinical setting has not been performed.
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.
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
APR 0 3 2014 KI32105
510(k) Summary
| Date: | April 03, 2014 |
|---|---|
| Submitter: | CryoLife, Inc. |
| Address: | 1655 Roberts Boulevard NW |
| Kennesaw, GA 30144 | |
| Phone: | 770-419-3355 |
| Fax: | 770-590-3783 |
| Contact: | Kimberly DiCono |
| Device Trade Name: | PerClot® Topical |
| Common Name: | Topical hemostatic particles |
| 510(k) Number: | K132105 |
| Proposed Classification Name: | Dressing, Pre-Amendment Unclassified |
| Product Code: | FRO - General and Plastic Surgery |
Predicate Device Information:
| Device Name | Company | 510(k) Clearance | Product Code |
|---|---|---|---|
| NexStat® Topical | |||
| Hemostat Powder | Hemostasis, LLC | ||
| 5000 Township Parkway | |||
| St. Paul, MN 55110 | K102459 | FRO |
Device Description:
PerClot® Topical is a medical device composed of absorbable polysaccharide granules and delivery applicators. The granules are biocompatible, non-pyrogenic and derived from purified potato starch. The granules do not contain any human or animal components. PerClot granules have a molecular structure that rapidly absorbs water, forming a gelled adhesive matrix that provides a mechanical barrier to further bleeding and results in the concentration of platelets, red blood cells, and coagulation proteins (thrombin, fibrinogen, etc.) at the site of application. The gelled adhesive matrix thus promotes the normal physiological clotting cascade. PerClot granules are enzymatically degraded by alpha-amylase and glucoamylase and by macrophages.
1
Intended Use:
PerClot Topical is intended for use under the care of a health care professional as a topical dressing for the temporary treatment of mildly bleeding wounds such as surgical wounds (postoperative, donor sites, dermatological), cuts and lacerations and for the treatment of mild bleeding from topical ENT surgical wounds and nosebleeds. It is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access, and percutaneous catheter access sites.
Bench Testing:
Functional testing demonstrated that PerClot is substantially equivalent when compared to the predicate device.
Performance Testing:
Studies demonstrated that PerClot meets the total water absorption, rate of water absorption, adhesion/cohesion, and particle/granule size distribution specifications. The function of the product is directly related to these performance specifications. A Pre-clinical GLP evaluation was conducted according to applicable standards. This study supports PerClot's is safety and effectiveness.
Substantial Equivalence to Predicate Device:
PerClot Topical is substantially equivalent to the predicate device.
Clinical Testing:
Evaluation in a clinical setting has not been performed.
Conclusion:
Based on the functional test results, pre-clinical, and biocompatibility studies performed in accordance with ISO 10993, these products behave similarly and are substantially equivalent.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 3, 2014
CryoLife Incorporated Ms. Kimberly DiCono Regulatory Affairs Manager 1655 Roberts Boulevard Northwest Kennesaw, Georgia 30144
Re: K132105
Trade/Device Name: PerClot Topical Regulatory Class: Unclassified Product Code: FRO Dated: February 26, 2014 Received: February 27, 2014
Dear Ms. DiCono:
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
3
Page 2 - Ms. Kimberly DiCono
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K132105
Device Name: PerClot Topical
Indications for Use:
PerClot Topical is intended for use under the care of a health care professional as a topical dressing for the temporary treatment of mildly bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological), cuts and laceration and for the treatment of mild bleeding from topical ENT surgical wounds and nosebleeds. It is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access, and percutaneous catheter access sites.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jiyoung Dang -S
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