Partial and full-thickness wounds
Pressure ulcers
Venous ulcers
Diabetic ulcers
Chronic vascular ulcers
Tunneled/undermined wounds
Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
Trauma wounds (abrasions, lacerations, partial-thickness burns, and skin tears)
Draining wounds

Device Description

Corplex P/Theracor P/Allacor P is derived from human umbilical cord extracellular matrix (ECM) and is indicated for the management of a range of acute and chronic wounds. As a resorbable particulate device, Corplex P/Theracor P/Allacor P is lyophilized and packaged in a sterile vial, allowing the device to be rehydrated and applied directly to the wound.

AI/ML Overview

This document describes a 510(k) premarket notification for a wound dressing device, Corplex P/Theracor P/Allacor P. It focuses on demonstrating substantial equivalence to a predicate device, Myriad Particles, rather than proving the device meets specific performance criteria through a comparative effectiveness study in the context of an AI-powered medical device.

Therefore, many of the requested categories related to AI device performance, such as sample size for test sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, and training set details, are not applicable to the information provided in this 510(k) submission.

This submission is about a traditional medical device (wound dressing) aiming for clearance based on substantial equivalence, not a novel AI/ML device that requires extensive clinical validation of its algorithm's performance against human readers or a robust ground truth.

Here's an attempt to answer the applicable questions based on the provided text:

1. Acceptance Criteria and Device Performance

The submission does not outline specific, quantified performance "acceptance criteria" in the way one would for an AI algorithm's diagnostic accuracy (e.g., "sensitivity must be >X%, specificity >Y%"). Instead, it demonstrates "substantial equivalence" to a predicate device by comparing various technological characteristics and presenting results of non-clinical (performance and biocompatibility) and clinical (human repeat insult patch test, skin prick test) testing to show that differences do not raise new safety or effectiveness concerns.

Table of Performance Testing (Non-Clinical):

Test	Result
Pour Test – Dry	PASS
Solution Compatibility Test	PASS
Digestion Assay	PASS
Pour Test – Wet	PASS
Absorption Test	PASS
Evaporation Test	PASS
Extracellular Matrix Characterization	PASS

Table of Biocompatibility Testing Results (All Met Requirements):

Cytotoxicity: ISO 10993-5:2009
Materials Mediated Pyrogenicity: ISO 10993-11:2017
Sensitization: ISO 10993-10:2010
Acute Systemic Toxicity: ISO 10993-11:2017
Intracutaneous Reactivity: ISO 10993-10:2021
Implantation: ISO 10993-6:2016
Chemical Characterization and Toxicological Risk Assessment: ISO 10993-18:2020, ISO 10993-17:2002, ISO 21726:2019
Genotoxicity: 10993-3:2014, ISO 10993-33:2015
Viral Risk Assessment and Clearance Study
Endotoxin: ANSI/AAMI/ST72
Packaging System Cytotoxicity: ISO 10993-5:2009

Clinical Testing:

Human Repeat Insult Patch Test
Skin Prick Test

The text states that these tests were conducted to "demonstrate substantial equivalence... or to mitigate any potential performance risks" and that results "meet the requirements" (for biocompatibility). No specific numerical thresholds or performance metrics are provided for these tests, as the goal is conformance to standards and equivalence, not a quantitative measure of superior performance an AI device might exhibit.

2. Sample Size for the Test Set and Data Provenance

Not applicable in the context of an AI/ML device's test set. The clinical testing mentioned (Human Repeat Insult Patch Test, Skin Prick Test) would have used human subjects, but their sample sizes are not disclosed in this document. These are typical safety evaluations for skin-contacting devices, not performance evaluations like those for AI.

3. Number of Experts used to establish the Ground Truth for the Test Set and the Qualifications of those Experts

Not applicable. Ground truth, in the AI context of expert consensus, is not relevant here. The "ground truth" for this device's testing would be defined by the results of the specific ASTM, ISO, or other standardized tests performed (e.g., a certain level of endotoxin, or a negative cytotoxicity finding). These are objective measurements from laboratory tests, not subjective interpretations by human experts.

4. Adjudication Method for the Test Set

Not applicable. There's no subjective interpretation requiring adjudication in the tests described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, this is not an MRMC study. This is a submission for a wound dressing device, not an AI diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. There is no algorithm or AI component in this device.

7. The Type of Ground Truth Used

The "ground truth" for this medical device's clearance is a combination of:

Conformance to established standards: e.g., ISO 10993 series for biocompatibility.
Comparison to a predicate device: showing that the new device's characteristics and performance are "substantially equivalent" and do not raise new safety or effectiveness concerns compared to a legally marketed device.
Laboratory test results: demonstrating properties like moisture content, dissolution, etc., meet internal specifications or are comparable to the predicate.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable.

Summary

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February 2, 2024

StimLabs, LLC Melissa O'Connor Chief Quality and Regulatory Affairs Officer 1225 Northmeadow Parkway. Suite 104 Roswell, Georgia 30076

Re: K231325

Trade/Device Name: Corplex P/Theracor P/Allacor P Regulatory Class: Unclassified Product Code: KGN Dated: January 2, 2024 Received: January 3, 2024

Dear Melissa O'Connor:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Yu-chieh Chiu -S

Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive 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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Indications for Use

510(k) Number (if known) K231325

Device Name Corplex P/Theracor P/Allacor P

Indications for Use (Describe) Corplex P/Theracor P/Allacor P is indicated for use in the management of the following wounds:

Partial and full-thickness wounds
Pressure ulcers
Venous ulcers
· Diabetic ulcers
· Chronic vascular ulcers
· Tunneled/undermined wounds
· Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
· Trauma wounds (abrasions, lacerations, partial-thickness burns, and skin tears)
Draining wounds

Type of Use (Select one or both, as applicable):

Remediation Under Part 21, CFR 221, Subpart E	Source Term Correction Under CFR 221, Subpart G
---------------------------------------------------------------------------------------	-----------------------------------------------------------------------------------------

|X | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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1. SUBMITTER/510(K) HOLDER:

StimLabs, LLC, FEI# 3012823434 1225 Northmeadow Parkway, Suite 104 Roswell, Georgia 30076 Phone: (888) 346-9802 Contact Person: Melissa O'Connor, M.S., RAC, CTBS, FRAPS Chief Quality and Regulatory Officer

Date Prepared: 02 Feb 2024

2. DEVICE NAME:

Trade name : Corplex P/Theracor P/Allacor P Product Code: KGN Common name: Wound Dressing with Animal-Derived Materials Classification name: Unclassified

3. PREDICATE DEVICE:

Predicate Device: Myriad Particles Manufacturer: Aroa Biosurgery, LTD K200502, KGN, Unclassified

Reference Device: InnovaMatrix PD Manufacturer: Triad Life Sciences, Inc. K211902, KGN, Unclassified

Reference Device: Prokera Manufacturer: BioTissue, Inc. K032104, NQB, Class II Medical Device (21 CFR 886.3130)

4. DEVICE DESCRIPTION

న్. INTENDED USE

Corplex P/Theracor P/Allacor P is intended to cover, protect, and provide a moist wound environment.

1 Corplex P, Theracor P, and Allacor P are different brand names of the same product and are entirely identical with no changes or differences to product design, manufacturing, intended use, or indications for use.

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6. INDICATIONS FOR USE

Corplex P/Theracor P/Allacor P is indicated for use in the management of the following wounds:

. Partial and full-thickness wounds
Pressure ulcers
Venous ulcers
Diabetic ulcers ●
Chronic vascular ulcers ●
. Tunneled/undermined wounds
Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound ● dehiscence)
Trauma wounds (abrasions, lacerations, partial-thickness burns, and skin tears) ●
Draining wounds .

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALNCE 7.

Corplex P/Theracor P/Allacor P is substantially equivalent to the predicate device, Myriad Particles (K200502) with respect to intended use, indications for use, configuration, components, moisture content, and sterility assurance level.

The primary differences between Corplex P/Theracor P/Allacor P and predicate devices are size/volume, nominal particle size, material source, collagen content (% total weight), total glycosaminoglycans (mg/g), packaging, sterilization method, and shelf life.

Triad Life Sciences' InnovaMatrix PD (K211902) and BioTissue's Prokera (K032104) are noted as reference devices to substantiate that the differences noted between Corplex P/Theracor P/Allacor P and Myriad Particles, primarily the difference in raw material source, do not raise additional questions or safety or effectiveness that have not already been mitigated by the performance, biocompatibilty and clinical testing described within this submission.

Corplex P/Theracor P/Allacor P is therefore substantially equivalent to the predicate device, Myriad Particles.

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K231325

Corplex PTM/Theracor PTM/Allacor P™ Substantial Equivalence Table
Sponsor	StimLabs, LLC	Aroa Biosurgery, LTD	Comparison	Triad Life Sciences, Inc.	BioTissue, Inc
510(k) Number	K231325	K200502	N/A	K211902	K032104
Device Name	Corplex P/Theracor P/Allacor P	Myriad Particles	N/A	InnovaMatrix PD	Prokera
Classification	Unclassified	Unclassified	Same	Unclassified	Class II, 886.3130
Product Code	KGN	KGN	Same	KGN	NQB
Size/Volume	1 cc2 cc4 cc	500 mg1000 mg	Different, but does notaffect safety andeffectiveness.	Mass offering up to ≤1000 mg	Classic, Plus, Slim, Clear
Nominal ParticleSizes	Particles ranging from0.1 mm to 2.0 mm	Particles ranging from0.25 mm to 2.00 mm	Different, but does notaffect safety andeffectiveness.	Particles ≤ 1000 μm (1mm)	OD=21.6 mmID= 15.5 mm or 17.9 mmHeight= 1.1 mm or 0.7mm
Indications for Use	Corplex P/Theracor P/Allacor Pis indicated for use in themanagement of the followingwounds:• Partial and full-thicknesswounds• Pressure ulcers• Venous ulcers• Diabetic ulcers• Chronic vascular ulcers• Tunneled/underminedwounds• Surgical wounds (donorsites/grafts, post-Moh'ssurgery, post-lasersurgery, podiatric, wounddehiscence)• Trauma wounds(abrasions, lacerations,partial-thickness burns,and skin tears)	Myriad Particles is indicatedfor use in the management ofthe following wounds:• Partial and full-thickness wounds• Pressure ulcers• Venous ulcers• Diabetic ulcers• Chronic vascularulcers• Tunneled/underminedwounds• Surgical wounds(donor sites/grafts,post-Moh's surgery,post-laser surgery,podiatric, wounddehiscence)• Trauma wounds(abrasions,	Same	InnovaMatrix™ isindicated for themanagement of woundsincluding:• partial- and full-thickness wounds• pressure ulcers• venous ulcers• diabetic ulcers• chronic vascularulcers• tunneled/underminedwounds• surgical wounds(donor sites/grafts,post-Mohs surgery,post-laser surgery,podiatric, wounddehiscence)• trauma wounds(abrasions,lacerations, second-	Prokera is intended foruse in eyes in whichocular surface cells aredamaged or underlyingstroma is inflamed orscarred and best suited toprevent adhesion of theeyelid to the ocularsurface with the largeophthalmic conformer.Acting as a self-retainingbiologic corneal bandage,Prokera effectively treatssuperficial cornealsurface diseases bysuppressing inflammationand related pain,promoting epithelialhealing, and avoidinghaze. Prokera is insertedbetween the eyeball andthe eyelid to maintainspace in the orbital cavity
	Draining wounds	lacerations, partial-thickness burns, and skin tears)Draining wounds		degree burns and skin tears)draining wounds.	and to prevent closure or adhesions. Placement of the conformer also enables application of the cryopreserved amniotic membrane to the ocular surface without the need for sutures.
Configuration	Particles	Particles	Same	Particles	Cryopreserved Corneal-epithelial insert consisting of ophthalmic conformer and amniotic membrane
Material Source	Human umbilical cord (recovered per 21 CFR 1271)	Ovine forestomach	Different, but does not affect safety and effectiveness.	Porcine placenta	Human amniotic membrane (recovered per 21 CFR 1271)
Components	Collagen and associated ECM components -collagen I -collagen III -collagen V	Collagen and associated ECM components -collagen I -collagen III -collagen V	Same	Collagen, extracellular matrix	Collagen, extracellular matrix
Collagen (% total mass)	46% (Mean Value)	>70%	Similar to predicate device, ECM characterization supports substantial equivalence	Present, composed primarily of collagen	Present
Total Glycosaminoglycans (mg/g)	20.3 mg/g (Mean Value)	>0.05 mg/g	Similar to predicate device, ECM characterization supports substantial equivalence	Present	Present
Endotoxin (EU/device)	<20 EU/device	<20 EU/device	Same	Unknown	Unknown
Packaging	Glass vial with bromobutyl stopper and aluminum crimped lid, inside single peel-open pouch	Polymer blister tray with a matching lid adhered to tray lip	Different. Differences were evaluated by biocompatibility and performance testing and support SE.	Double peel-open packages	Double peel-open pouches
Sterilization	Sterilized by electron beam irradiation	Sterilized by ethylene oxide	Different, but does not affect safety and effectiveness.	Sterilized by electron beam irradiation	Aseptically processed
Moisture Content	<15%*	< 30% w/w*	Same	Unknown	Unknown
Sterility Assurance Level	10-6	10-6	Same	10-6	N/A
Shelf Life	One Year	Unknown	Different, but does not affect safety and effectiveness.	Two Months	Two Years
Prescription or OTC	Prescription	Prescription	Same	Prescription	Prescription
Single or Multiple Use	Single Use	Single Use	Same	Single Use	Single Use

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K231325

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K231325

*Residual moture is calculated by Stimler virant which represents the percentage of water content remaints and mature by weget (mas) loss and is presented as "weight per weight". The units of measurement as presented are equivalent.

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8. PERFORMANCE TESTING

The following non-clinical performance testing was conducted to demonstrate substantial equivalence of Corplex P/Theracor P/Allacor P to the predicate device or to mitigate any potential performance risks related to the differences between Corplex P/Theracor P/Allacor P, the predicate, and reference devices:

Corplex P/Theracor P/Allacor P Performance Testing
Pour Test – Dry	PASS
Solution Compatibility Test	PASS
Digestion Assay	PASS
Pour Test – Wet	PASS
Absorption Test	PASS
Evaporation Test	PASS
Extracellular Matrix Characterization	PASS

9. BIOCOMPATIBILITY TESTING

Corplex P/Theracor P/Allacor P is categorized for long term (>30 days) contact with breached and/or compromised skin surfaces. Biocompatibility testing was conducted in accordance with the US Food and Drug Administration Guidance entitled Use of International Standard ISO-10993: 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' and test results meet the requirements.

Cytotoxicity: ISO 10993-5:2009 Tests for in vitro cytotoxicity ●
Materials Mediated Pyrogenicity: ISO 10993-11:2017 Tests for systemic toxicity .
Sensitization: ISO 10993-10:2010 Tests for irritation and skin sensitization .
Acute Systemic Toxicity: ISO 10993-11:2017 Tests for systemic toxicity ●
Intracutaneous Reactivity: ISO 10993-10:2021 Tests for irritation and skin sensitization ●
Implantation: ISO 10993-6:2016 Tests for local effects after implantation, ●
Chemical Characterization and Toxicological Risk Assessment: ISO 10993-18:2020, ISO 10993-17:2002, ISO 21726:2019
Genotoxicity: 10993-3:2014, ISO 10993-33:2015
Viral Risk Assessment and Clearance Study ●
Endotoxin: ANSI/AAMI/ST72, Bacterial Endotoxins Test Methodologies, routine ● monitoring, and alternative batch testing
. Packaging System Cytotoxicity: ISO 10993-5:2009- Tests for in vitro cytotoxicity

10. CLINICAL TESTING

The following clinical testing was conducted to demonstrate substantial equivalence of Corplex P/Theracor P/Allacor P to the predicate device and to mitigate any potential safety risks in human subjects related to the differences between Corplex P/Theracor P/Allacor P, the predicate, and reference devices:

Human Repeat Insult Patch Test
. Skin Prick Test

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11. CONCLUSION

Corplex P/Theracor P/Allacor P has the same intended use, indications for use, configuration, components, moisture content, and sterility assurance level as Myriad Particles. The differences between Corplex P/Theracor P/Allacor P and the predicate device do not raise different questions of safety or effectiveness. The combination of performance testing, biocompatibility, and clinical testing, as well as the incorporation of reference devices to justify the differences, demonstrate that Corplex P/Theracor P/Allacor P is as safe and effective as and substantially equivalent to the predicate device.

Regulation Number and Section

N/A