Corplex P/ Theracor P/ Allacor P

• K Number: K242828
• Device Name: Corplex P/ Theracor P/ Allacor P
• Manufacturer: StimLabs, LLC
• Date Cleared: 2024-10-18 ( 29 days)
• Product Code: KGN
• Regulation Number: N/A
• Type: Special
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: K231325
• Predicate For: N/A

Intended 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

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

The provided text describes a 510(k) premarket notification for a medical device called Corplex P/Theracor P/Allacor P. It states that the device is identical to its predicate device (K231325) in most aspects, with a minor modification being the addition of an 8 cc configuration. The document explicitly states that this modification does not raise new questions of safety or effectiveness and therefore, no new clinical testing, biocompatibility testing, or extensive performance studies were required to demonstrate substantial equivalence.

Instead, the submission relies on the established performance of the predicate device and verification testing related to the minor design change.

Therefore, many of the requested details about acceptance criteria, detailed study design, sample sizes, expert involvement, and ground truth establishment, which are typically associated with performance studies, are not explicitly present in this summary document because such extensive studies were deemed unnecessary for this 510(k) submission.

Here's an attempt to answer your questions based on the provided text, indicating where information is not available due to the nature of this submission:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative format for all characteristics. Instead, it relies on the device being "identical" or having "same" or "does not raise new questions of safety and effectiveness" compared to the predicate device. For the one specific test mentioned (Bioburden Testing), the outcome is a simple "PASS".

Characteristic	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (K242828)
Size/Volume	Must not raise new questions of safety and effectiveness compared to 1 cc, 2 cc, and 4 cc configurations.	1 cc, 2 cc, 4 cc, 8 cc (The additional 8cc configuration was deemed to "not raise new questions of safety and effectiveness")
Nominal Particle Sizes	Same as predicate: Particles ranging from 0.1 mm to 2.0 mm (must pass through 2.00 mm aperture sieve and not pass through 0.106 mm aperture sieve, ASTM E11).	Particles ranging from 0.1 mm to 2.0 mm (Same as predicate: Particles must be able to pass through a 2.00 mm aperture calibrated sieve and not pass through a 0.106 mm aperture calibrated sieve (ASTM E11) when manually sieved.)
Intended Use	Same as predicate: To cover, protect, and provide a moist wound environment.	Same
Indications for Use	Same as predicate for specified wound types.	Same
Configuration	Same as predicate: Particles.	Same
Material Source	Same as predicate: Human umbilical cord (recovered per 21 CFR 1271).	Same
Components	Same as predicate: Collagen and associated ECM components (collagen I, collagen III, collagen V).	Same
Collagen (% total weight)	Same as predicate: 46% (Mean Value).	46% (Mean Value)
Total Glycosaminoglycans (mg/g)	Same as predicate: 20.3 mg/g (Mean Value).	20.3 mg/g (Mean Value)
Endotoxin (EU/device)	Same as predicate: <20 EU/device.	<20 EU/device
Packaging	Must not raise new questions of safety or effectiveness compared to 6 mL glass vial.	10 mL Glass vial with bromobutyl stopper and aluminum crimped lid, inside single peel-open pouch (Deemed to "not raise new questions of safety or effectiveness" when compared to the 6 mL vial of the predicate)
Sterilization	Same as predicate: Sterilized by electron beam irradiation.	Same
Moisture Content	Same as predicate: <15%.	<15%
Sterility Assurance Level	Same as predicate: 10-6.	10-6
Shelf Life	Same as predicate: One Year.	One Year
Bioburden Testing	Acceptable result based on methods used for predicate clearance.	PASS

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily relies on the substantial equivalence to a predicate device (K231325). For the specific modification (8 cc configuration), verification testing was performed.

• Test Set Sample Size: Not specified for the bioburden testing or other verification tests mentioned. The document states "Testing was performed based on the risk assessment for the proposed change using the same methods used to support the clearance of the predicate device."
• Data Provenance: Not explicitly stated. Given it's a 510(k) submission to the US FDA by a US-based company (StimLabs, LLC, Roswell, Georgia), the data is most likely from the US, and refers to prior data from the predicate device. It is not a clinical study, so terms like "retrospective" or "prospective" are not applicable to the verification testing conducted for this submission. The predicate device's data would have been part of its original 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This submission is for a material device, not an AI or diagnostic device that requires expert ground truth for image interpretation or similar tasks. The "ground truth" for the characteristics listed would be defined by standard laboratory testing methodologies and specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The verification testing mentioned (e.g., bioburden) involves laboratory results rather than expert adjudication of interpretations.

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

No. This is a wound dressing made from human umbilical cord extracellular matrix, not an AI or diagnostic device.

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

No. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the verification testing related to the new device, the ground truth would be defined by standard laboratory test results and established acceptance criteria for physical and chemical properties (e.g., bioburden levels, particle size distribution, moisture content, collagen content, endotoxin levels). For the predicate substantial equivalence, the "ground truth" refers to the established safety and effectiveness of the existing legally marketed device.

8. The sample size for the training set

Not applicable. This is not a machine learning or 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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October 18, 2024

StimLabs, LLC Melissa O'connor Chief Ouality and Regulatory Officer 1225 Northmeadow Parkway Suite 104 Roswell, Georgia 30076

Re: K242828

Trade/Device Name: Corplex P/ Theracor P/ Allacor P Regulatory Class: Unclassified Product Code: KGN Dated: September 18, 2024 Received: September 19, 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"

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(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).

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 OS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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.

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Mustafa A. Mazher -S

For Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of 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

Enclosure

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Indications for Use

510(k) Number (if known) K242828

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)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

1. SUBMITTER/510(K) HOLDER:

StimLabs, LLC, FEI# 3012823434 1225 Northmeadow Parkway, Suite 104 Roswell. Georgia 30076 Phone: [phone] Contact Person: Melissa O'Connor, M.S., RAC, CTBS, FRAPS Chief Quality and Regulatory Officer

Date Prepared: 17 Oct 2024

2. DEVICE NAME:

Trade name1: Corplex P/Theracor P/Allacor P Product Code: KGN Common name: Wound Dressing with Animal-Derived Materials Classification name: Unclassified

3. PREDICATE DEVICE:

Trade name: Corplex P/Theracor P/Allacor P (K231325; Unclassified) Product Code: KGN Manufacturer: StimLabs, LLC

4. 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.

న. INTENDED USE

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

INDICATIONS FOR USE 6.

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 .

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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• 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

7. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALNCE

Corplex P/Theracor P/Allacor P is identical to the predicate device. Corplex P/Theracor P/Allacor P (K231325) with respect to intended use, indications for use, technological characteristics, operational characteristics, components, moisture content, and sterility assurance level. A minor modification has been made to the device's design to include an 8 cc configuration. The modifications do not prevent the subject device from performing in a substantially equivalent manner to the predicate device. Based on a risk assessment, appropriate verification testing was performed, yielding acceptable results. The differences in design do not raise new questions of safety and effectiveness compared to the predicate device.

Corplex P/Theracor P/Allacor P is substantially equivalent to the predicate device.

8. VERIFICATION AND VALIDATION TESTING

The following verification testing was conducted to demonstrate substantial equivalence of Corplex P/Theracor P/Allacor P to the predicate device and to mitigate any potential risks related to the differences in design between Corplex P/Theracor P/Allacor P and the predicate device:

Corplex P/Theracor P/Allacor P Verification Testing
Bioburden Testing	PASS

Testing was performed based on the risk assessment for the proposed change using the same methods used to support the clearance of the predicate device.

BIOCOMPATIBILITY TESTING 9.

The modification to design did not raise new questions of safety or effectiveness pertaining to the biocompatibility of the subject device; therefore, biocompatibility testing was neither required nor performed.

10. CLINICAL TESTING

The modification to design did not raise new questions of safety or effectiveness pertaining to the previous clinical testing performed for the predicate device. Additional clinical testing was neither required nor performed to support demonstration of substantial equivalence.

11. CONCLUSION

Corplex P/Theracor P/Allacor P is identical to the predicate device, Corplex P/Theracor P/Allacor P (K231325) with respect to intended use, indications for use, technological characteristics, operational characteristics, components, moisture content, and sterility assurance level. The design differences raised by this modification do not raise new questions of safety or effectiveness. The verification testing

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performed demonstrates that Corplex P/Theracor P/Allacor P is as safe and effective compared to the predicate and is substantially equivalent to the predicate device.

Corplex P/Theracor P/ Allacor P Substantial Equivalence Table
Sponsor	StimLabs, LLC	StimLabs, LLC	Comparison
510(k) Number	K242828	K231325	N/A
Device Name	Corplex P/ Theracor P/ Allacor P	Corplex P/ Theracor P/ Allacor P	Same
Classification	Unclassified	Unclassified	Same
Product Code	KGN	KGN	Same
Size/Volume	1 cc2 cc4 cc8 cc	1 cc2 cc4 cc	Does notraise newquestions ofsafety andeffectiveness
Nominal ParticleSizes	Particles ranging from0.1 mm to 2.0 mm	Particles ranging from0.1 mm to 2.0 mm	Same
Intended Use	Corplex P is intended to cover,protect, and provide a moist woundenvironment.	Corplex P is intended to cover, protect,and provide a moist woundenvironment.	Same
Indications for Use	Corplex P is indicated for use in themanagement of the following wounds:• Partial and full-thickness wounds• Pressure ulcers• Venous ulcers• Diabetic ulcers• Chronic vascular ulcers• Tunneled/undermined wounds• Surgical wounds (donorsites/grafts, post-Moh's surgery,post-laser surgery, podiatric,wound dehiscence)• Trauma wounds (abrasions,lacerations, partial-thicknessburns, and skin tears)• Draining wounds	Corplex P is indicated for use in themanagement of the following wounds:• Partial and full-thicknesswounds• Pressure ulcers• Venous ulcers• Diabetic ulcers• Chronic vascular ulcers• Tunneled/undermined wounds• Surgical wounds (donorsites/grafts, post-Moh's surgery,post-laser surgery, podiatric,wound dehiscence)• Trauma wounds (abrasions,lacerations, partial-thicknessburns, and skin tears)• Draining wounds	Same
Configuration	Particles	Particles	Same
Material Source	Human umbilical cord (recovered per21 CFR 1271)	Human umbilical cord (recovered per21 CFR 1271)	Same
Components	Collagen and associated ECMcomponents-collagen I-collagen III-collagen V	Collagen and associated ECMcomponents-collagen I-collagen III-collagen V	Same
Collagen (% totalweight)	46% (Mean Value)	46% (Mean Value)	Same
TotalGlycosaminoglycans(mg/g)	20.3 mg/g (Mean Value)	20.3 mg/g (Mean Value)	Same
Endotoxin(EU/device)	<20 EU/device	<20 EU/device	Same
Packaging	10 mL Glass vial with bromobutylstopper and aluminum crimped lid,inside single peel-open pouch	6 mL Glass vial with bromobutylstopper and aluminum crimped lid,inside single peel-open pouch	Does notraise newquestions ofsafety oreffectiveness
Sterilization	Sterilized by electron beam irradiation	Sterilized by electron beam irradiation	Same
Moisture Content	<15%*	<15%*	Same
Particle Size	Particles must be able to pass througha 2.00 mm aperture calibrated sieveand not pass through a 0.106 mmaperture calibrated sieve (ASTM E11)when manually sieved.	Particles must be able to pass through a2.00 mm aperture calibrated sieve andnot pass through a 0.106 mm aperturecalibrated sieve (ASTM E11) whenmanually sieved.	Same
Sterility AssuranceLevel	10-6	10-6	Same
Shelf Life	One Year	One Year	Same
Prescription or OTC	Prescription	Prescription	Same
Single or MultipleUse	Single Use	Single Use	Same

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*Residual moisture by StimLabs via a chemical reaction which represents the persentent maints after lyophilization. The Predicate

Regulation Number and Section

N/A