(270 days)
No
The summary describes a biological wound dressing derived from human umbilical cord ECM. There is no mention of any computational or algorithmic components, let alone AI/ML. The performance studies focus on material properties and biocompatibility, not algorithmic performance.
Yes
The device is indicated for use in the management of various types of wounds, aiming to treat or alleviate a medical condition.
No
Explanation: The device is described as a material derived from human umbilical cord extracellular matrix, indicated for the management of the listed wounds. It is a resorbable particulate device that is applied directly to the wound, implying 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 is for the management of various types of wounds. This involves applying the device directly to the wound for therapeutic purposes (wound healing).
- Device Description: The device is a resorbable particulate derived from human umbilical cord extracellular matrix, applied directly to the wound.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue) to provide information about a disease or condition. Its function is to aid in wound management, not to diagnose or monitor a condition through in vitro testing.
IVD devices are used outside the body to examine specimens from the body to provide diagnostic information. This device is applied to the body for a therapeutic purpose.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
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
Prescription Use (Part 21 CFR 801 Subpart D)
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 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:
- 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
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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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).
1
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
2
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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3
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
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.
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.
4
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 cc | ||||
2 cc | |||||
4 cc | 500 mg | ||||
1000 mg | Different, but does not | ||||
affect safety and | |||||
effectiveness. | Mass offering up to ≤ | ||||
1000 mg | Classic, Plus, Slim, Clear | ||||
Nominal Particle | |||||
Sizes | Particles ranging from | ||||
0.1 mm to 2.0 mm | Particles ranging from | ||||
0.25 mm to 2.00 mm | Different, but does not | ||||
affect safety and | |||||
effectiveness. | Particles ≤ 1000 μm (1 | ||||
mm) | OD=21.6 mm | ||||
ID= 15.5 mm or 17.9 mm | |||||
Height= 1.1 mm or 0.7 | |||||
mm | |||||
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) | Myriad Particles 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, | Same | InnovaMatrix™ is | |||
indicated for the | |||||
management of wounds | |||||
including: | |||||
• partial- and full- | |||||
thickness wounds | |||||
• pressure ulcers | |||||
• venous ulcers | |||||
• diabetic ulcers | |||||
• chronic vascular | |||||
ulcers | |||||
• tunneled/undermined | |||||
wounds | |||||
• surgical wounds | |||||
(donor sites/grafts, | |||||
post-Mohs surgery, | |||||
post-laser surgery, | |||||
podiatric, wound | |||||
dehiscence) | |||||
• trauma wounds | |||||
(abrasions, | |||||
lacerations, second- | Prokera is intended for | ||||
use in eyes in which | |||||
ocular surface cells are | |||||
damaged or underlying | |||||
stroma is inflamed or | |||||
scarred and best suited to | |||||
prevent adhesion of the | |||||
eyelid to the ocular | |||||
surface with the large | |||||
ophthalmic conformer. | |||||
Acting as a self-retaining | |||||
biologic corneal bandage, | |||||
Prokera effectively treats | |||||
superficial corneal | |||||
surface diseases by | |||||
suppressing inflammation | |||||
and related pain, | |||||
promoting epithelial | |||||
healing, and avoiding | |||||
haze. Prokera is inserted | |||||
between the eyeball and | |||||
the eyelid to maintain | |||||
space 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) | 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.