(183 days)
Not Found
No
The summary describes a collagen wound dressing and its physical properties and performance in animal studies. There is no mention of AI or ML technology.
Yes
The device is indicated for the management of various types of wounds, aiming to facilitate healing and provide a moist wound environment, which are therapeutic actions.
No
The device description and intended use indicate that scaffolene® CL100 Bioresorbable Collagen Matrix is a wound dressing used for the management and healing of wounds, not for diagnosing medical conditions.
No
The device description clearly states it is a "collagen wound dressing provided sterile" and describes its physical properties and how it is used as a material applied to wounds, indicating it is a physical medical device, 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 that the device is for the "management of full and partial thickness wounds in adult patients." This describes a therapeutic or wound care device applied directly to the body, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a "collagen wound dressing" that is applied to the wound, maintains a moist environment, and supports exudate management. This aligns with the function of a wound care product, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.), analyze biomarkers, or provide diagnostic information.
Therefore, scaffolene® CL100 Bioresorbable Collagen Matrix is a wound care device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
scaffolene® CL100 Bioresorbable Collagen Matrix is indicated for the management of full and partial thickness wounds in adult patients including:
Pressure ulcers Diabetic ulcers Ulcers caused by mixed vascular etiologies Venous ulcers Second degree burns Donor and graft sites Abrasions Dehisced surgical wounds Traumatic wounds healing by secondary intention
Product codes (comma separated list FDA assigned to the subject device)
KGN
Device Description
scaffolene® CL100 Bioresorbable Collagen Matrix is a collagen wound dressing provided sterile, which maintains a moist wound environment and supports exudate management. It can be cut to wound size, is a pliable absorbent dressing and can be adapted to irregular wound surfaces. scaffolene® CL100 Bioresorbable Collagen Matrix is resorbable and it can be left in place during secondary dressing changes.
scaffolene® CL100 Bioresorbable Collagen Matrix will typically resorb in about 1-3 days (shown in wound healing study in vivo), although this will be influenced by the patient's overall health. It is not necessary to remove the wound dressing.
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
Adult patients
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)
Non-Clinical Data/Information was provided to support a determination of substantial equivalence, including:
- Sterilization and Shelf-Life (Gamma Irradiation, Real-Time Aging to 1.5 Years)
- Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Materials Mediated Pyrogenicity, Subacute/Subchronic Toxicity, Genotoxicity, Implantation, Chemical Characterization and Toxicological Risk Assessment)
- Animal-Derived Materials Safety Information (Animal Source, Virus Safety Risk Assessment, Collagen Characterization)
- Performance Testing Bench (Water Uptake, Protein Digestion, Unfoldability, Microscopic Appearance, Hot Water Stability, Conformability)
- Performance Testing Animal (Rat Wound Healing Study, Porcine Wound Healing Study)
Non-clinical data demonstrate that scaffolene® CL100 Bioresorbable Collagen Matrix is as safe and as effective as the predicate device.
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.
Covalon Technologies ColActive® Transfer (K123756)
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.
Not Found
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 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 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.
February 28, 2020
Freudenberg Technology Innovation SE & Co. KG % Sugato De Vice President - Technical Parexel International 4600 East-West Highway, Suite 350 Bethesda, Maryland 20814
Re: K192346
Trade/Device Name: scaffolene CL100 Bioresorbable Collagen Matrix Regulatory Class: Unclassified Product Code: KGN Dated: August 28, 2019 Received: August 29, 2019
Dear Sugato De:
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. 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 located 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.
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 803) for
1
devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.
Kimberlv M. Ferlin. Ph.D. Assistant Director (Acting) DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192346
Device Name
scaffolene® CL100 Bioresorbable Collagen Matrix
Indications for Use (Describe) scaffolene® CL100 Bioresorbable Collagen Matrix is indicated for the management of full and partial thickness wounds in adult patients including:
Pressure ulcers Diabetic ulcers Ulcers caused by mixed vascular etiologies Venous ulcers Second degree burns Donor and graft sites Abrasions Dehisced surgical wounds Traumatic wounds healing by secondary intention
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image contains the logo for Freudenberg. The logo consists of a blue wave-like graphic on the left, followed by the company name "FREUDENBERG" in a bold, sans-serif font, also in blue. Below the company name, the tagline "INNOVATING TOGETHER" is written in a smaller, lighter font.
510(k) Summary as required by 21 CFR 807.92(c)
scaffolene® CL100 Bioresorbable Collagen Matrix
| Date Prepared: | February 26, 2020 |
|---|---|
| Submitter: | Freudenberg Technology Innovation SE & Co. KG |
| Hoehnerweg 2-4 | |
| 69469 Weinheim, Germany | |
| Official Contact: | Sugato De, M.S. |
| Vice President - Technical | |
| Parexel International | |
| 4600 East-West Highway, Suite 350 | |
| Bethesda, MD 20814, USA | |
| Phone: +1 301 634 5515 | |
| Fax: +1-301 634 8040 | |
| Email: us-agent@parexel.com | |
| Proprietary Name: | scaffolene® CL100 Bioresorbable Collagen Matrix |
| Common Name: | Collagen Wound Dressing |
| Classification: | Unclassified, Preamendment |
| Product Code: KGN | |
| Predicate Device: | Covalon Technologies ColActive® Transfer (K123756) |
| Reason for Submission: | New Device |
Device Description
scaffolene® CL100 Bioresorbable Collagen Matrix is a collagen wound dressing provided sterile, which maintains a moist wound environment and supports exudate management. It can be cut to wound size, is a pliable absorbent dressing and can be adapted to irregular wound surfaces. scaffolene® CL100 Bioresorbable Collagen Matrix is resorbable and it can be left in place during secondary dressing changes.
scaffolene® CL100 Bioresorbable Collagen Matrix will typically resorb in about 1-3 days (shown in wound healing study in vivo), although this will be influenced by the patient's overall health. It is not necessary to remove the wound dressing.
Indications for Use
scaffolene® CL100 Bioresorbable Collagen Matrix is indicated for the management of full and partial thickness wounds in adult patients including:
- . Pressure ulcers
- Diabetic ulcers
- Ulcers caused by mixed vascular etiologies ●
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Image /page/4/Picture/1 description: The image contains the logo for Freudenberg. The logo consists of a blue graphic element resembling waves or mountains, followed by the word "FREUDENBERG" in a bold, sans-serif font, also in blue. Below the company name, the tagline "INNOVATING TOGETHER" is written in a smaller, lighter blue font.
- Venous ulcers ●
- . Second degree burns
- Donor and graft sites ●
- Abrasions ●
- Dehisced surgical wounds ●
- Traumatic wounds healing by secondary intention .
Technological Characteristics
The indications for use for scaffolene® CL100 Bioresorbable Collagen Matrix are identical to those of the Covalon Technologies ColActive® Transfer (K123756). scaffolene® CL100 Bioresorbable Collagen Matrix has similar technological differences to those of the Covalon Technologies ColActive® Transfer (K123756), with differences in material characteristics, device design, resorption period, primary packaging, and device shelf-life.
Non-Clinical Data/Information
The following non-clinical data/information were provided to support a determination of substantial equivalence:
- Sterilization and Shelf-Life .
- Gamma Irradiation O
- Real-Time Aging to 1.5 Years O
- Biocompatibility ●
- Cytotoxicity o
- Sensitization o
- o Intracutaneous Reactivity
- Acute Systemic Toxicity O
- o Materials Mediated Pyrogenicity
- Subacute/Subchronic Toxicity O
- o Genotoxicity
- Implantation o
- Chemical Characterization and Toxicological Risk Assessment o
- Animal-Derived Materials Safety Information ●
- Animal Source O
- Virus Safety Risk Assessment o
- o Collagen Characterization
- Performance Testing Bench
- O Water Uptake
- Protein Digestion O
- Unfoldability o
- Microscopic Appearance O
- Hot Water Stability o
- O Conformability
- Performance Testing Animal ●
- Rat Wound Healing Study o
- Porcine Wound Healing Study o
.
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Image /page/5/Picture/1 description: The image shows the logo for Freudenberg. The logo consists of a blue graphic element resembling waves or hills, followed by the word "FREUDENBERG" in bold, blue letters. Below the company name, the tagline "INNOVATING TOGETHER" is written in smaller, blue letters.
Conclusion
Non-clinical data demonstrate that scaffolene® CL100 Bioresorbable Collagen Matrix is as safe and as effective as the predicate device. In conclusion, scaffolene® CL100 Bioresorbable Collagen Matrix is substantially equivalent to the Covalon Technologies ColActive® Transfer (K123756).