(82 days)
The device is intended for the management of minor scrapes, minor bruises, minor abrasions, minor lacerations, and minor burns.
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.
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.
This document is a 510(k) summary for medical devices, specifically Cellusheet Dressing and Cellufil Particles, seeking Over-The-Counter (OTC) clearance. It compares these devices to their previously cleared Prescription Use (Rx) predicates, SkinTemp II Dressing and Medifil II Particles, respectively. The core of the submission argues for substantial equivalence primarily based on the devices being identical to their predicates in all aspects except the change from Rx to OTC indication for use.
Here's a breakdown of the requested information, though much of it regarding acceptance criteria and separate performance studies is not applicable or not explicitly detailed in this type of submission, which focuses on substantial equivalence rather than new performance data for this specific submission.
1. A table of acceptance criteria and the reported device performance
This 510(k) submission is for a "Special 510(k)" which modifies the Indications for Use from Prescription (Rx) to Over-The-Counter (OTC) for two previously cleared devices. Therefore, the acceptance criteria and device performance reported are not against new performance standards, but rather demonstrate that the device remains substantially equivalent to its predicates, which already met their respective performance criteria. The document explicitly states: "The subject devices are the same as the predicate devices in all technological characteristics, geometric specifications, packaging, sterilization, manufacturing process and raw materials used. The subject devices do not raise any different questions of safety and effectiveness with regards to the technological characteristics."
Essentially, the acceptance criterion for this submission is Substantial Equivalence to the predicate devices, established by demonstrating no changes in design, materials, manufacturing, or other technological characteristics that would raise new questions of safety or effectiveness for the proposed OTC use.
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance (vs. Predicate) |
|---|---|
| Intended Use Comparison: Similar intended use. | Same: "Management of wounds" for both Cellusheet Dressing/Cellufil Particles and SkinTemp II Dressing/Medifil II Particles. |
| Indications for Use Comparison: Proposed indications for use do not raise new questions of safety or effectiveness. | Different, but argued as equivalent: Proposed OTC indications are "Intended for management of minor cuts, minor scrapes, minor bruises, minor abrasions, minor lacerations, and minor burns." Predicate Rx indications are broader: "The device is intended for the management of burns, sores, blisters, scrapes, ulcers and other wounds." The document argues: "The difference in indications from prescription to OTC do not raise different questions of safety or effectiveness. The use of these products for minor wounds is intuitive. Similar products already exist in the OTC market (see K081724)." |
| Technological Characteristics Comparison: Similar design, materials, sterilization, shelf life, configurations, etc. | Same: - Sterilization: E-beam. Product supplied STERILE.- Storage Conditions: Store in a cool and dry place.- Design: Soft, sterile, disposable, absorbent & conformable single-use wound dressing with non-adherent backing (Cellusheet); Bovine collagen wound dressing that is sterile, off-white powder (Cellufil).- Primary Constituent Materials: Bovine Collagen, Demineralized Water (Cellusheet only), Buffering agent / Chemical Z.- Usage Type: Single Patient Use.- Shelf Life: 5 years.- Configurations/Particle Size: 2"X2", 3"X4", 8"X12" (Cellusheet); 0.1mm-0.3mm (Cellufil).- Packaging: 5 sheets/pouches per box.- Device Class/Product Code: Unclassified, KGN. |
| Biocompatibility: No new biocompatibility concerns. | Same: "All testing performed on predicate will be applicable since there is no change in the product specifications. All testing was performed as per FDA biocompatibility guidance on ISO 10993." |
| Product Integrity/Stability: No new concerns over shelf-life. | Same: "the product integrity testing over the shelf-life period will also be applicable to the subject device in this case." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission does not describe a new "test set" or new performance data for the devices. The basis for substantial equivalence is that the devices are identical to previously cleared predicate devices except for the change in marketing from Rx to OTC. Therefore, no new clinical or non-clinical studies specifically for a "test set" for this submission were conducted or reported here. The document states: "The subject devices are the same as the predicate devices... 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."
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. As this is a Special 510(k) based on substantial equivalence to existing predicate devices, no new "test set" requiring expert-established ground truth for device performance is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new test set or clinical study requiring adjudication is described in this submission.
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
Not applicable. This document pertains to wound dressings and particles, not AI software or diagnostic imaging devices that would typically involve MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for this Special 510(k) submission. The "ground truth" for the predicate devices, which established their safety and effectiveness for their original Rx indications, would have relied on standard testing and potentially clinical data appropriate for wound care products at the time of their original clearance (K122325, K910944, K925545). This information is not detailed in the current submission.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a "training set."
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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
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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
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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:
| SerialNumber | Device Identification in theSubmission | 510(k) Number | Prescription Use (Rx)Name | Over-The-Counter(OTC) Name |
|---|---|---|---|---|
| 1 | Device 1 | K122325K925545K913023 | SkinTemp II Dressing | Cellusheet Dressing |
| 2 | Device 2 | K925545K910944 | 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)
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K213092 Page 2 of 7
Image /page/4/Picture/1 description: The image contains the logo for Human Biosciences. The word "HUMAN" is in blue, and the word "BIOSCIENCES" is in red. To the right of the text is an image of a red and blue double helix.
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" | < 17% | 5 Years |
| CS5001 | 3"X4" | < 17% | 5 Years |
| CS5002 | 8"X12" | < 17% | 5 Years |
Device Constituents
- Bovine Collagen
- Demineralized Water ●
- Buffering agent (HBS Proprietary Name "Chemical Z") ●
Device 1 Illustrations
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Image /page/5/Picture/0 description: The image shows two figures of Cellusheet Dressing. Figure 0-1 shows the Cellusheet Dressing, and Figure 0-2 shows the non-adherent backing of the Cellusheet Dressing. The image also contains the text 'K213092 Page 3 of 7' and the logo for 'HUMAN BIOSCIENCES'.
DEVICE 2-CELLUFIL PARTICLES
Description
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)].
Product List
| HBS Reorder Number | Size and Packaging | Moisture Content | Shelf Life |
|---|---|---|---|
| CF6000 | 1 gm in Pouch | < 17% | 5 Years |
Device Constituents
- Bovine Collagen
- Buffering agent (HBS Proprietary Name "Chemical Z") ●
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K213092 Page 4 of 7
Image /page/6/Picture/1 description: The image contains the logo for Human Biosciences. The words "HUMAN" and "BIOSCIENCES" are stacked on top of each other, with "HUMAN" in blue and "BIOSCIENCES" in red. To the right of the text is an image of what appears to be a strand of DNA in red, white, and blue.
Device 2 Illustration
Image /page/6/Picture/3 description: A pile of white powder is on a gray surface. The powder is in a small, irregular heap, with some of it scattered around the base. The surface is a speckled gray color, possibly a countertop or other flat surface. The lighting is bright and even, highlighting the texture of both the powder and the surface.
Figure 3: Cellufil Particles
Indications for Use (for Device 1 and 2):
Intended for management of minor cuts, minor scrapes, minor abrasions, minor abrasions, minor lacerations, and minor burns.
Summary of Technological Characteristics
The Cellusheet Dressing and Cellufil Particles are comparable in technological characteristics to the predicate devices: Human Biosciences Inc SkinTemp II Dressing and Medifil II Particles respectively per 21 CFR Part 807.92(a)(5). The following tables show where the subject devices are similar to and different from the predicate devices in terms of technological characteristics.
DEVICE 1 (CELLUSHEET DRESING) - SUBSTANTIAL EQUIV ALENCE SUMMARY
- Predicate Device: SkinTemp II Dressing
- 510(k) Number: K122325
- Name of Manufacturer: Human Biosciences Inc
Table 1-1: Substantial equivalence comparison between predicate device and submission device
| Detail | Predicate Device | Submission Subject | Comparison |
|---|---|---|---|
| SkinTemp II Dressing | DeviceCellusheet Dressing | ||
| 510(k) Number | K122325 | K213092 | N/A |
| Intended Use | Management of wounds | Management of wounds | Same |
| Indications for Use | The device is intended forthe management of burns,sores, blisters, scrapes,ulcers and other wounds. | Intended formanagement of minorcuts, minor scrapes,minor bruises, minorabrasions, minorlacerations, and minorburns. | Different |
| Sterilization | E-beam. Product suppliedSTERILE | E-beam. Product supplied STERILE | Same |
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K213092 Page 5 of 7
| Storage Conditions | Store in a cool and dry place | Store in a cool and dry place | Same |
|---|---|---|---|
| Design | Soft, sterile, disposable, absorbent & conformable single use wound dressing with non-adherent backing. | Soft, sterile, disposable, absorbent & conformable single use wound dressing with non-adherent backing. | Same |
| Primary ConstituentMaterials | Bovine CollagenBovine CollagenDemineralized WaterBuffering agent /Chemical Z (proprietary name) | Bovine CollagenBovine CollagenDemineralized WaterBuffering agent /Chemical Z (proprietary name) | Same |
| Usage Type | Single Patient Use | Single Patient Use | Same |
| Shelf Life | 5 years | 5 years | Same |
| Configurations | 2"X2", 3"X4" and 8"X12" | 2"X2", 3"X4" and 8"X12" | Same |
| Packaging | 5 sheets per box | 5 sheets per box | Same |
| Rx vs. OTC | Rx | OTC | Different |
| Device Class andProduct Code | Unclassified, KGN | Unclassified, KGN | Same |
| Biocompatibility | All testing was performed as per FDA biocompatibility guidance on ISO 10993 | All testing performed on predicate will be applicable since there is no change in the product specifications. | Same |
DEVICE 2 (CELLUFIL PARTICLES) - SUBSTANTIAL EQUIVALENCE SUMMARY
- Predicate Device: Medifil II Particles ●
- 510(k) Number: K910944 & K925545
- Name of Manufacturer: Biocore Medical Technologies/Human Biosciences Inc ●
- . Substantial Equivalence Comparison
Table 1-2: Substantial equivalence comparison between predicate device and submission device
| Detail | Predicate DeviceMedifil II Particles | Submission Subject DeviceCellufil Particles | Comparison |
|---|---|---|---|
| 510(k) Number | K910944 & K925545 | K213092 | N/A |
| Intended Use | Management of wounds | Management of wounds | Same |
| Indications for Use | The device is intended for themanagement of burns, sores,blisters, scrapes, ulcers and otherwounds. | Intended for management ofminor cuts, minor scrapes, minorbruises, minor abrasions, minorlacerations, and minor burns. | Different |
| Sterilization | E-beam. Product suppliedSTERILE | E-beam. Product suppliedSTERILE | Same |
| Storage Conditions | Store in a cool and dry place | Store in a cool and dry place | Same |
| Design | Medifil II Particles is a bovine(cattle) collagen wound dressingthat is sterile. | Cellufil Particles is a bovine(cattle) collagen wound dressingthat is sterile. | Same |
Special 510(k) for Cellusheet Dressing (SkinTemp II Dressing) and Cellufil Particles (Medifil II Particles) K213092 Page 5 of 7
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K213092 Page 6 of 7
| Primary ConstituentMaterials | Bovine CollagenBovine CollagenBuffering agent / Chemical Z(proprietary name) | Bovine CollagenBovine CollagenBuffering agent / Chemical Z(proprietary name) | Same |
|---|---|---|---|
| Particle Size | 0.1mm – 0.3mm | 0.1mm – 0.3mm | Same |
| Usage Type | Single Patient Use | Single Patient Use | Same |
| Shelf Life | 5 years | 5 years | Same |
| Configuration | 1gram powder in one pouch | 1gram powder in one pouch | Same |
| Packaging | 5 powder pouches per box | 5 powder pouches per box | Same |
| Rx v/s OTC | Rx | OTC | Different |
| Device Class andProduct Code | Unclassified, KGN | Unclassified, KGN | Same |
| Biocompatibility | All testing was performed as perFDA biocompatibility guidanceon ISO 10993. | All testing performed on predicatewill be applicable since there is nochange in the productspecifications. | Same |
Reference Device (K081724) Description - Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound Gel
Hydrolyzed Collagen with 10% Chondroitin Sulfate (PSGAG, Polysulfated glycosaminoglycan) Wound Gel is a line extension of the previously cleared HyCure® Hydrolyzed Collagen (K955506). Hydrolyzed Collagen with 10% Chondroitin Sulfate (PSGAG, Polysulfated glycosaminoglycan) contains Chondroitin Sulfate as Chondroprotec® previously cleared for market via 510(k) (K961930). Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound Gel contains a high concentration of water bound to the hydrolyzed collagen which maintains a moist wound environment as it manages wound healing. Hydrolyzed Collagen with 10% Chondroitin Sulfate (PSGAG, Polysulfated glycosaminoglycan).
Device Changes From Predicates
The intent of this special 510(k) is to modify the previously cleared SkinTemp II Dressing (K122325) and Medifil II Particles (K910944, K925545) manufactured by Human Biosciences Inc to include Over-the-counter use. The devices subject of this submission are the same devices as the cleared devices under 510(k) number K122325 and K910944/K925545, respectively.
Difference in Indications for Use
The subject devices and the predicate devices share intended use. The difference in indications from prescription to OTC do not raise different questions of safety or effectiveness. The use of these products for minor wounds is intuitive. Similar products already exist in the OTC market (see K081724).
Summary of Non-Clinical Testing
The subject devices are the same as the predicate devices in all technological characteristics, geometric specifications, packaging, sterilization, manufacturing process and raw materials used. The subject devices do not raise any different questions of safety and effectiveness with regards to the technological characteristics. The biocompatibility testing performed on the predicate devices
Special 510(k) for Cellusheet Dressing (SkinTemp II Dressing) and Cellufil Particles (Medifil II Particles) K213092 Page 6 of 7
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K213092 Page 7 of 7
Image /page/9/Picture/1 description: The image is a logo for "Human Biosciences". The word "HUMAN" is in blue, and the word "BIOSCIENCES" is in red. To the right of the words is a graphic of two tubes, one red and one blue, that appear to be intertwined. The tubes have a white background.
will be applicable to the subject devices since there is no change to the technological characteristics of the device. Additionally, the product integrity testing over the shelf-life period will also be applicable to the subject device in this case. 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. 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.
Conclusion
The Cellusheet Dressing (Device 1) and Cellufil Particles (Device 2) are substantially equivalent to the respective predicate devices, SkinTemp II Dressing (K122325) and Medifil II Particles (K910944, K925545), with OTC support from the K081724 predicate:
-
Both the devices have same intended use.
-
All the devices have similar technological characteristics in terms of primary constituent, raw material used, sterilization method, geometric specifications and design of the device.
Biocompatibility tests, stability test, and sterilization performed on the predicate devices are applicable to the current devices and hence raise no new questions on safety and effectiveness are raised.
Hence, a determination of substantial equivalence is supported.
N/A