(82 days)
No
The device description and performance studies focus on the material composition and physical properties of the wound dressing, with no mention of AI or ML capabilities.
No.
The device is a wound dressing intended for minor wounds, which are generally not considered therapeutic in the sense of actively treating or curing a disease, but rather providing a suitable environment for healing.
No
The device description indicates it is a wound dressing that absorbs drainage and provides a moist wound environment, intended for the management of minor wounds. It does not mention any function related to diagnosing medical conditions.
No
The device description clearly describes physical wound dressings (Cellusheet Dressing and Cellufil Particles) made of collagen, which are tangible, physical products, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside of the body.
- Device Description and Intended Use: The description clearly states that the device is a wound dressing intended for the management of topical wounds (scrapes, bruises, lacerations, burns). It is applied directly to the wound on the body.
- Mechanism of Action: The device works by absorbing wound drainage and providing a moist wound environment, which are physical actions on the wound itself, not diagnostic tests performed on a specimen.
The information provided describes a wound care product, not a diagnostic test.
N/A
Intended Use / Indications for Use
The device is intended for the management of minor scrapes, minor bruises, minor abrasions, minor lacerations, and minor burns.
Product codes (comma separated list FDA assigned to the subject device)
KGN
Device Description
Cellusheet Dressing is a soft, sterile, disposable, absorbent & conformable single use wound dressing. It is hydrophilic dressing composed of fibrous bovine collagen and a non-adherent backing layer. The dressing absorbs wound drainage to cover the topical wounds to provide moist wound environment. The Cellusheet Dressing will be available in 2"X2" and 8"X12" sizes.
Cellusheet Dressing is made up of collagen which is the most abundant protein in the human body and to cover the topical wounds to provide moist wound environment.
The dressing will be packaged in a single use Tyvek pouch (1059B). Each Tyvek Pouch will contain one dressing sheet. 5 Tyvek pouches will be packaged in a box. Sterility is guaranteed for unopened and undamaged packaging.
The bovine collagen used in this device is derived from cowhides that are sourced from certified negligible Bovine Spongiform Encephalopathy (BSE) risk region designated by the World Organization for Animal Health [formerly the OIE (Office International des Epizooties)].
Cellufil Particles is a bovine (cattle) collagen wound dressing that is sterile, off-white powder that absorbs wound drainages. The dressing is an off-white, colored powder made up of collagen cover the topical wounds to provide moist wound environment. Cellufil Particles consists of spherical hydrophilic particles 0.1mm to 0.3mm in diameter.
The particles will be packaged in single use Tyvek pouch (1059B). Each Tyvek Pouch will contain one gram of the powder. 5 Tyvek pouches will be packaged in a box.
The bovine collagen used to make this device is derived from cowhides that are sourced from certified negligible Bovine Spongiform Encephalopathy (BSE) risk region designated by the World Organization for Animal Health [formerly the OIE (Office International des Epizooties)].
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
Over-The-Counter Use
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 submission states "All the testing was submitted in K122325 for SkinTemp II Dressings i.e., the predicate for Device 1 and K910944 for Medifil II Particles i.e., the predicate for Device 2." and that "The only difference between the subject devices and the predicate devices is an Over-The-Counter indication for use compared to Prescription Use Only for the predicate devices." No new performance studies are described.
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 is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
December 15, 2021
Human Biosciences, Inc. % Jack Slovick VP Quality & Regulatory Methodize P.O. Box 463 Nevis, Minnesota 56467
Re: K213092
Trade/Device Name: Cellusheet, Cellufil Regulatory Class: Unclassified Product Code: KGN Dated: July 30, 2021 Received: September 24, 2021
Dear Jack Slovick:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 medical devices and radiation-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,
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213092
Device Name Cellusheet Dressing and Cellufil Particles
Indications for Use (Describe)
The device is intended for the management of minor scrapes, minor bruises, minor abrasions, minor lacerations, and minor burns.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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K213092 Page 1 of 7
Image /page/3/Picture/1 description: The image shows the logo for Human Biosciences. The text "HUMAN BIOSCIENCES" is written in large, bold, blue letters. Above the text is an image of two intertwined strands, one red and one blue, with white accents. The logo is clean and professional, and the colors are eye-catching.
510(k) Summary [As required by 21CFR 807.92 (c)]
510k #: K213092 Date Summary Prepared: July 30, 2021 Submitter Information Name of Manufacturer/Owner of 510(k): Human Biosciences Inc Address: 940 Clopper Rd, Gaithersburg, MD 20878 FDA Establishment Registration Number: 3008770963 Contact Person: Primary Contact: Jack Slovick (Vice President of Quality & Regulatory) Secondary Contact: Jigar Patel (Operations Manager)
Email Address: Jack Slovick: ilslovick@gmail.com Phone Number: +1 - 301 - 740 - 1893 Fax Number: +1 - 301 - 740 - 1899 Name Change
A name change is proposed to the Device Name/Trade Name for both the products part of this submission. For OTC variants of the products, the following names are proposed:
| Serial
Number | Device Identification in the
Submission | 510(k) Number | Prescription Use (Rx)
Name | Over-The-Counter
(OTC) Name |
|------------------|--------------------------------------------|-------------------------------|-------------------------------|--------------------------------|
| 1 | Device 1 | K122325
K925545
K913023 | SkinTemp II Dressing | Cellusheet Dressing |
| 2 | Device 2 | K925545
K910944 | Medifil II Particles | Cellufil Particles |
Submission Type and Product Information
Type of 510(k) submission: Special
Device 1
Subject: Name of Device/Trade Name (OTC): Cellusheet Dressing Predicate: Name of Device/Trade Name (Rx): SkinTemp II Dressing (K122325)
Device 2 Subject: Name of Device/Trade Name (OTC): Cellufil Particles Predicate: Name of Device/Trade Name (Rx): Medifil II Particles (K910944 & K925545)
Additional Reference Device:
Name of Device/Trade Name (OTC): Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound Gel (K081724)
4
K213092 Page 2 of 7
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Product Classification Details:
- Device: Dressing, Wound, Collagen
- 트 Product Code: KGN
- Device Class: Unclassified
- Unclassified Reason: Pre-Amendment Device
- 트 Premarket Review: Infection Control and Plastic Surgery Devices (DHT4B)
Device Information
DEVICE 1 - CELLUSHEET DRESSING
Description
Cellusheet Dressing is a soft, sterile, disposable, absorbent & conformable single use wound dressing. It is hydrophilic dressing composed of fibrous bovine collagen and a non-adherent backing layer. The dressing absorbs wound drainage to cover the topical wounds to provide moist wound environment. The Cellusheet Dressing will be available in 2"X2" and 8"X12" sizes.
Cellusheet Dressing is made up of collagen which is the most abundant protein in the human body and to cover the topical wounds to provide moist wound environment.
The dressing will be packaged in a single use Tyvek pouch (1059B). Each Tyvek Pouch will contain one dressing sheet. 5 Tyvek pouches will be packaged in a box. Sterility is guaranteed for unopened and undamaged packaging.
The bovine collagen used in this device is derived from cowhides that are sourced from certified negligible Bovine Spongiform Encephalopathy (BSE) risk region designated by the World Organization for Animal Health [formerly the OIE (Office International des Epizooties)].
Product List
| HBS Reorder Number | Size | Moisture Content | Shelf Life |
|---|---|---|---|
| CS5000 | 2"X2" |