ProgenaMatrix

K182010 · Cell Constructs I, LLC · KGN · Jan 17, 2019 · SU

Device Facts

• Record ID: K182010
• Device Name: ProgenaMatrix
• Applicant: Cell Constructs I, LLC
• Product Code: KGN · SU
• Decision Date: Jan 17, 2019
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Indications for Use

ProgenaMatrix™ is indicated for dry and exuding partial and full thickness wounds such as: pressure (stage I-IV) and venous stasis ulcers caused by mixed vascular etiologies, diabetic ulcers, donor sites and grafts, first and second degree burns, superficial injuries, cuts, abrasions and surgical wounds. ProgenaMatrix™ is not intended to be used on third degree burns.

Device Story

ProgenaMatrix™ is a clear keratin matrix derived from human hair; designed to assist wound healing by maintaining a moist wound environment. Packaged in a sterile, moisture-proof, peel-open pouch containing water and propylene glycol. Applied topically to the wound site by a clinician. Acts as a wound dressing to facilitate healing. Benefits include moisture management for various wound types.

Clinical Evidence

Clinical testing included Repeat Insult Patch Test and Skin Prick Test. Additional non-clinical bench testing evaluated tensile strength, moisture vapor transmission rate, water transmission rate, degradation potential, manufacturing residuals, viral inactivation, protein characterization, and contaminant removal. Comprehensive biocompatibility testing performed including cytotoxicity, sensitization, irritation, acute/chronic toxicity, genotoxicity, carcinogenicity, and pyrogenicity.

Technological Characteristics

Keratin matrix derived from human hair. Supplied in sterile, moisture-proof pouch with water and propylene glycol. Mechanical properties include tensile strength, moisture vapor transmission, and degradation potential. Biocompatible material.

Indications for Use

Indicated for patients with dry and exuding partial and full thickness wounds, including pressure ulcers (stage I-IV), venous stasis ulcers, diabetic ulcers, donor sites, grafts, first and second degree burns, superficial injuries, cuts, and abrasions. Contraindicated for third degree burns.

Predicate Devices

• Keratec Wound Dressings (a/k/a Keraderm, now known as Keramatrix®) (K080949)

Reference Devices

• Hyalomatrix® (K073251)

Submission Summary (Full Text)

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January 17, 2019

Cell Constructs I, LLC % Elizabeth O'Keefe Regulatory Affairs Director Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188

Re: K182010

Trade/Device Name: ProgenaMatrix™ Regulatory Class: Unclassified Product Code: KGN Dated: December 18, 2018 Received: December 18, 2018

#### Dear Elizabeth O'Keefe:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Anjana Jain -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.

510(k) Number (if known) K182010 Device Name

ProgenaMatrix™

Indications for Use (Describe)

ProgenaMatrix™ is indicated for dry and exuding partial and full thickness wounds such as: pressure (stage I-IV) and venous stasis ulcers caused by mixed vascular etiologies, diabetic ulcers, donor sites and grafts, first and second degree burns, superficial injuries, cuts, abrasions and surgical wounds.

ProgenaMatrix™ is not intended to be used on third degree burns.

Type of Use (Select one or both, as applicable) 区 Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (7/17)

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## 510(k) Summary of Safety and Effectiveness

In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the Cell Constructs I, LLC ProgenaMatrix™ is provided below.

| Date | 01/16/2019 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted by | Cell Constructs I, LLC<br>2275 Northwest Pkwy SE, Suite 170<br>Marietta, GA 30067<br>Phone : [phone] |
| 510(k) Contact | Secure BioMed Evaluations<br>Elizabeth O'Keeffe, Ph.D.<br>7828 Hickory Flat Highway Suite 120<br>Woodstock, GA 30188<br>770-837-2681 (direct)<br>[e-mail] |
| Trade Name | ProgenaMatrix™ |
| Common Name | Dressing, Wound, Collagen |
| Code -Classification | KGN: Unclassified |
| Primary Predicate | K080949 Keratec Wound Dressings (a/k/a Keraderm, now known as Keramatrix®) |
| Reference Devices | K073251 Hyalomatrix® |
| Device Description | ProgenaMatrix™ is a clear keratin matrix derived from human hair designed to<br>assist wound healing by facilitating a moist wound healing environment. It is<br>packaged in a sterile, moisture-proof, peel-open pouch containing water and<br>propylene glycol. |
| Intended Use | ProgenaMatrix™ is indicated for dry and exuding partial and full thickness<br>wounds such as: pressure (stage I-IV) and venous stasis ulcers, ulcers caused by<br>mixed vascular etiologies, diabetic ulcers, donor sites and grafts, first and<br>second degree burns, superficial injuries, cuts, abrasions and surgical wounds.<br>ProgenaMatrix™ is not intended to be used on third degree burns. |
| Technological<br>Characteristics | The subject device has substantially equivalent technological characteristics as<br>the predicate device and/or the reference device in terms of principles of<br>operation, intended use, material performance, and biocompatibility. |
| Non-Clinical<br>Testing | The subject device has mechanical properties substantially equivalent to the |
| | predicate device with the same intended use. The following characteristics were |
| | evaluated: |
| | • Tensile Strength |
| | • Moisture Vapor Transmission Rate |
| | • Water Transmission Rate |
| | • Degradation Potential |
| | • Manufacturing Residuals |
| | • Viral Inactivation<br>• Protein Characterization<br>• Removal of Contaminants |
| Biocompatibility<br>Testing | • Cytotoxicity |
| | • Sensitization |
| | • Irritation |
| | • Acute Toxicity |
| | • Subacute & Subchronic Toxicity (Implantation Endpoint Assessment) |
| | • Endotoxin Testing |
| | • Pyrogenicity |
| | • Toxicological Risk Assessment |
| | • Chronic Toxicity |
| | • Genotoxicity |
| | • Carcinogenicity |
| Clinical Testing | • Repeat Insult Patch Test |
| | • Skin Prick Test |
| Conclusions | ProgenaMatrix™ has the same intended use, principles of operation and |
| | substantially equivalent technological characteristics as Keratec Wound Dressing |
| | (a/k/a Keraderm, now known as Keramatrix®). While ProgenaMatrix™ differs |
| | from the predicate device in the source of keratin protein (human vs. sheep), |
| | both devices share the same mode of action in that they assist in providing a |
| | moist wound healing environment. ProgenaMatrix™ is substantially equivalent |
| | with respect to safety and effectiveness to the predicate and reference devices |
| | and does not raise different questions of safety and effectiveness. |

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