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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the PerClot Topical device:

This 510(k) summary for PerClot Topical does not describe a study involving an AI/Machine Learning device or a direct comparison to human performance. Instead, it outlines the regulatory pathway for a conventional medical device (a topical hemostatic agent).

Therefore, many of your requested sections regarding AI-specific criteria, such as multi-reader multi-case studies, ground truth establishment for training sets, or expert qualifications for interpreting AI outputs, are not applicable to this document. I will focus on the information that is present and indicate where the requested information is not relevant to this type of submission.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria/Tests	Reported Device Performance
Functional Equivalence	Substantial equivalence to predicate device	PerClot is substantially equivalent compared to the predicate device (NexStat® Topical Hemostat Powder).
Performance Specifications	Total water absorption	Meets specifications.
	Rate of water absorption	Meets specifications.
	Adhesion/Cohesion	Meets specifications.
	Particle/granule size distribution specifications	Meets specifications.
Safety and Effectiveness	Pre-clinical GLP evaluation	Conducted according to applicable standards, supports safety and effectiveness.
Biocompatibility	Biocompatibility studies (ISO 10993)	Performed in accordance with ISO 10993.

"Study That Proves the Device Meets the Acceptance Criteria":

The document describes several types of testing that collectively demonstrate the device meets acceptance criteria:

Bench Testing: Functional testing demonstrated "substantial equivalence" to the predicate device (NexStat® Topical Hemostat Powder).
Performance Testing: Studies demonstrated that PerClot meets specific performance specifications related to water absorption (total and rate), adhesion/cohesion, and particle/granule size distribution. The document states, "The function of the product is directly related to these performance specifications."
Pre-clinical GLP Evaluation: This study was conducted according to applicable standards and is reported to support PerClot's safety and effectiveness.
Biocompatibility Studies: Performed in accordance with ISO 10993.

These tests, rather than a single overarching study, are presented as the evidence for meeting acceptance criteria.

Regarding AI/Machine Learning Specific Information (Not Applicable to this Document):

The following points are not applicable as this 510(k) pertains to a physical medical device (hemostatic particles) and not an AI/Machine Learning diagnostic or assistive device.

2. Sample size used for the test set and the data provenance: Not applicable. No test set of data (e.g., medical images, patient records) is mentioned for an AI device. The testing involved functional, performance, pre-clinical, and biocompatibility assessments of the material itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" establishment for an AI test set is relevant here. The ground truth refers to the physical properties and biological effects of the hemostatic particles.

4. Adjudication method for the test set: Not applicable. There is no test set in the context of AI evaluation.

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 not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI device. For this physical device, the "ground truth" would be the established scientific and engineering principles for hemostasis, material science, and biocompatibility, as evaluated through the described bench, performance, pre-clinical, and biocompatibility testing. No "expert consensus" on interpreting data for an algorithm is mentioned.

8. The sample size for the training set: Not applicable. No AI training set is mentioned.

9. How the ground truth for the training set was established: Not applicable. No AI training set is mentioned.

Summary

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APR 0 3 2014 KI32105

510(k) Summary

Date:	April 03, 2014
Submitter:	CryoLife, Inc.
Address:	1655 Roberts Boulevard NWKennesaw, 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® TopicalHemostat Powder	Hemostasis, LLC5000 Township ParkwaySt. Paul, MN 55110	K102459	FRO

Device Description:

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Intended Use:

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.

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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

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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

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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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Regulation Number and Section

N/A