(29 days)
No
The device description and performance studies focus on the biological properties and manufacturing process of the extracellular matrix material, with no mention of AI or ML.
Yes
The device is indicated for use in the management of various wounds, which falls under the definition of a therapeutic purpose.
No
The device is described as being indicated for "management of the following wounds," and is "applied directly to the wound," indicating a therapeutic rather than diagnostic function.
No
The device description clearly states it is derived from human umbilical cord extracellular matrix and is a resorbable particulate device, indicating it is a physical material, 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 the device is for the "management of the following wounds". This describes a therapeutic or wound care application, not a diagnostic test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description details a resorbable particulate device derived from human umbilical cord extracellular matrix, applied directly to the wound. This is consistent with a wound care product, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
The device is a wound care product intended for direct application to wounds.
N/A
Intended Use / Indications for Use
Corplex P/Theracor P/Allacor P is intended to cover, protect, and provide a moist wound environment.
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
Product codes
KGN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and 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.
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"
1
(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.
2
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,
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
3
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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4
510(k) Summary
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: 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.
5
- 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
6
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 cc | ||
| 2 cc | |||
| 4 cc | |||
| 8 cc | 1 cc | ||
| 2 cc | |||
| 4 cc | Does not | ||
| raise new | |||
| questions of | |||
| safety and | |||
| effectiveness | |||
| Nominal Particle | |||
| Sizes | Particles ranging from | ||
| 0.1 mm to 2.0 mm | Particles ranging from | ||
| 0.1 mm to 2.0 mm | Same | ||
| Intended Use | Corplex P is intended to cover, | ||
| protect, and provide a moist wound | |||
| environment. | Corplex P is intended to cover, protect, | ||
| and provide a moist wound | |||
| environment. | Same | ||
| Indications for Use | Corplex 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 | Corplex 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 | Same | ||
| Configuration | Particles | Particles | Same |
| Material Source | Human umbilical cord (recovered per | ||
| 21 CFR 1271) | Human umbilical cord (recovered per | ||
| 21 CFR 1271) | Same | ||
| 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 (% total | |||
| weight) | 46% (Mean Value) | 46% (Mean Value) | Same |
| Total | |||
| Glycosaminoglycans | |||
| (mg/g) | 20.3 mg/g (Mean Value) | 20.3 mg/g (Mean Value) | Same |
| Endotoxin | |||
| (EU/device) |