Who is the manufacturer of PuraPly Micronized Wound Matrix (PuraPly MZ)?

Organogenesis, Inc. filed the 510(k) submission for PuraPly Micronized Wound Matrix (PuraPly MZ) (K220317).

What is the FDA product code for PuraPly Micronized Wound Matrix (PuraPly MZ)?

KGN. as a Class U device in the SU panel.

What is the regulatory pathway for PuraPly Micronized Wound Matrix (PuraPly MZ)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for PuraPly Micronized Wound Matrix (PuraPly MZ)?

PuraPly® Wound Matrix (K011026).

Who can help prepare an FDA 510(k) submission like PuraPly Micronized Wound Matrix (PuraPly MZ)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PuraPly Micronized Wound Matrix (PuraPly MZ)

K220317 · Organogenesis, Inc. · KGN · Jul 1, 2022 · SU

Device Facts

Record ID	K220317
Device Name	PuraPly Micronized Wound Matrix (PuraPly MZ)
Applicant	Organogenesis, Inc.
Product Code	KGN · SU
Decision Date	Jul 1, 2022
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

PuraPly® Micronized Wound Matrix (PuraPly® MZ) is intended for the management of wounds.

Device Story

PuraPly® Micronized Wound Matrix (PuraPly® MZ) is a sterile, porcine collagen-based wound dressing supplied as a dry powder (particle size ≤ 1000μm). It is intended for the management of various wound types, including chronic ulcers, surgical wounds, and trauma wounds. The device is applied topically to the wound site by a clinician. It functions as a wound matrix to support the management of the wound environment. The device is for single-patient use and is not intended for implantation. It provides a collagen-based scaffold to assist in wound care management.

Clinical Evidence

No human clinical data provided. Evidence consists of non-clinical bench testing, including physical characterization (color, particle size, DSC, absorption, mixing ratio, pH, endotoxin) and a comprehensive biocompatibility battery per ISO 10993 standards (cytotoxicity, sensitization, irritation, pyrogenicity, acute/sub-acute/sub-chronic systemic toxicity, genotoxicity). A large animal wound healing study was also conducted.

Technological Characteristics

Material: Porcine collagen. Form: Dry powder (≤ 1000μm). Sterilization: Gamma irradiation. Biocompatibility: Conforms to ISO 10993-1, -3, -5, -6, -10, -11, -12. Connectivity: None (standalone).

Indications for Use

Indicated for management of partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (e.g., donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric wounds, wound dehiscence), trauma wounds (e.g., abrasions, lacerations, skin tears), partial thickness burns, and draining wounds. Single patient use only.

Predicate Devices

PuraPly® Wound Matrix (K011026)

Reference Devices

ACell MicroMatrix (K172399)

Related Devices

K061407 — PRIMATRIX DERMAL REPAIR SCAFFOLD · Tei Biosciences, Inc. · Jun 29, 2006
K103648 — COLLAGEN POWDER · Innocoll Pharmaceuticals, Ltd. · Sep 14, 2011
K060888 — ACELL POWDER WOUND DRESSING · Acell, Inc. · Jun 23, 2006
K153754 — MicroMatrix · Acell, Inc. · Mar 14, 2016
K112888 — MESO WOUND MATRIX · Kensey Nash Corporation · Feb 10, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font. July 1, 2022 Organogenesis Inc. Kurdea Lyon Program Manager, Regulatory Affairs 150 Dan Road Canton, Massachusetts 02021 Re: K220317 Trade/Device Name: PuraPly® Micronized Wound Matrix (PuraPly® MZ) Regulatory Class: Unclassified Product Code: KGN Dated: May 27, 2022 Received: June 1, 2022 Dear Kurdea Lyon: 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 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, Julie Morabito, PhD 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) K220317 Device Name PuraPly® Micronized Wound Matrix (PuraPly® MZ) Indications for Use (Describe) PuraPly® Micronized Wound Matrix (PuraPly® MZ) is intended for the management of wounds that include: - · Partial and full-thickness wounds - Pressure ulcers - Venous ulcers - · Diabetic ulcers - Chronic vascular ulcers - · Tunneled/undermined wounds · Surgical wounds (e.g., donor sites/grafts, post-Mohs' surgery, Podiatric wound, and wound dehiscence). - · Trauma wounds (e.g., abrasions, lacerations, and skin tears) - Partial thickness burns - Draining wounds The device is intended for single patient use only. Type of Use (*Select one or both, as applicable*)X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 6. 510(k) Summary ## Submitter Information per 21 CFR 807.92(a)(1) | SPONSOR: | Organogenesis Inc. 150 Dan Road Canton, Massachusetts, 02021 | |----------|--------------------------------------------------------------------| |----------|--------------------------------------------------------------------| | PRIMARY CONTACT: | Kurdea Lyon Manager, Regulatory Affairs Phone: (781) 401-1063 Email: klyon@organo.com | |--------------------|---------------------------------------------------------------------------------------------------------| | SECONDARY CONTACT: | John Ferros Vice President, Regulatory Affairs Phone: (781) 615-1833 Email: Jferros@organo.com | | MANUFACTURER: | Organogenesis Inc. 150 Dan Road Canton, Massachusetts, 02021 | |---------------|--------------------------------------------------------------------| |---------------|--------------------------------------------------------------------| | DATE PREPARED per 21 CFR 807.92(a)(1): | May 27, 2022 | |----------------------------------------|--------------| | | | # Device Information per 21 CFR 807.92(a)(2) | TRADE NAME OF SUBJECT DEVICE: | PuraPly® Micronized Wound Matrix (PuraPly® MZ) | |-------------------------------|------------------------------------------------| |-------------------------------|------------------------------------------------| | COMMON/USUAL NAME: | Dressing, Wound, Collagen | |--------------------|---------------------------| |--------------------|---------------------------| {4}------------------------------------------------ | DEVICE CLASS: | Unclassified | |----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------| | UNCLASSIFIED REASON: | Pre-Amendment | | PRODUCT CODE: | KGN | | PREDICATE DEVICE: | Primary Predicate Device: PuraPly® Wound Matrix (K011026) FDA cleared under Trade Name: FortaDerm Reference Device: ACell MicroMatrix (K172399) | {5}------------------------------------------------ #### Device Description per 21 CFR 808.92(a)(4) PuraPly® Micronized Wound Matrix (PuraPly® MZ) consists of micronized porcine collagen intended for the management of wounds. PuraPly® Micronized Wound Matrix is supplied as a dry powder of particle size of ≤ 1000μm. The device is sterile and packaged in a vial sealed in a single pouch. #### Intended Use per 21 CFR 807.92(A)(5) PuraPly @ Micronized Wound Matrix (PuraPly® MZ) is intended for the management of wounds. #### Indications for Use per FORM FDA 3881 PuraPly® Micronized Wound Matrix (PuraPly® MZ) is intended for the management of wounds that include: - Partial and full-thickness wounds ● - Pressure ulcers ● - Venous ulcers . - Diabetic ulcers . - . Chronic vascular ulcers - Tunneled/undermined wounds ● - Surgical wounds (e.g., donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric wounds, wound dehiscence, ) ● - Trauma wounds (e.g., abrasions, lacerations, and skin tears) . - Partial thickness burns . - Draining wounds . The device is intended for single patient use only. Do not reuse. Do not implant. #### Indications for Use Characteristics Comparison The subject and predicate devices have the same intended use and indication for use statement. #### Technological Characteristics Comparison with the predicate device per 21 CFR 807.92(a)(6) {6}------------------------------------------------ The technological characteristics comparison that the subject device is substantially equivalent in intended use, design, materials, and operational principles to the previously cleared predicate devices. ### Basis of Substantial Equivalence per 21 CFR 807.100(b)(2)(ii)(A) The substantial equivalence of the subject device was determined as per the FDA guidance document. "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" and the analysis of the technological characteristics which include materials, design, and other device features, as defined in section 513(i)(1)(B) of the FD&C Act and 21 CFR 807.100(b)(2)(ii)(A) demonstrates that the subject device is substantially equivalent to the predicate devices. The subject device design and features are substantially equivalent to the predicate in terms of safety and effectiveness and do not raise any new questions of safety and effectiveness. The performance testing, device comparison, and analysis device is substantially equivalent to the predicate device. The data generated in the performance test reports located in Section 19 compared the subject device and support a finding of substantial equivalence. {7}------------------------------------------------ # Comparison Table | Device Characteristics | Subject Device | Predicate Device | Reference Device | Substantial Equivalence Discussion | |------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Name | PuraPly® Micronized Wound Matrix PuraPly MZ | PuraPly® Wound Matrix | ACell™ MicroMatrix | N/A | | Applicant | Organogenesis Inc. | Organogenesis Inc. | ACell Incorporated | | | 510(k) Number | K220317 | K011026 | K172399 | | | Classification Regulation | Unclassified | Unclassified | Unclassified | Substantially Equivalent | | Product Code | KGN | KGN | KGN | Substantially Equivalent | | Indications for Use | The intended use of PuraPly® Micronized is for the management of wounds including: Partial and full thickness wounds Pressure ulcers, Venous ulcers, Diabetic ulcers, Chronic vascular ulcers Tunneled/unde rmined wounds Surgical wounds (e.g., donor sites/grafts, post-Moh's surgery, post laser surgery, podiatric, | The intended use of PuraPly® is for the management of wounds including: Partial and full thick wounds Pressure ulcers, Venous ulcers, Diabetic ulcers, Chronic vascular ulcers Tunneled/u ndermined wounds Surgical wounds (donor sites/grafts, post-Moh's surgery, post | The intended use of Acell™ for the management of wounds including: Partial and full thick wounds Pressure ulcers, Venous ulcers, Diabetic ulcers. Chronic vascular ulcers Tunneled/und ermined wounds Surgical wounds (donor sites/grafts, post- Moh's surgery, post laser surgery, podiatric, wound dehiscence) | Substantially Equivalent | | | | | | | | | wound dehiscence, ) • Trauma wounds (e.g., abrasions, lacerations, skin tears) • Partial thickness burns • Drainage wounds | laser surgery, podiatric, wound dehiscence) • Trauma wounds (abrasions, lacerations, skin tears) • Second- degree burns • Drainage wounds | • Trauma wounds (abrasions, lacerations, skin tears) • Second- degree burns • Drainage wounds | | | Sterile | Gamma Irradiation | Gamma Irradiation | Electron Beam irradiation | The sterilization method for the subject device is substantially equivalent to the primary predicate. The difference in sterilization method between the primary and reference predicates raises no additional concerns of safety and efficacy as both products are provided sterile. | | Materials | Porcine Collagen | Porcine Collagen | Porcine derived extracellular matrix known as urinary bladder matrix | The animal origin for the subject device is identical to the primary predicate. The difference in detailed origin between the subject device and reference | | | | | | | | | | | | device does not raise any question related to safety and efficacy as the material is similar and performance data demonstrated the products are substantially equivalent | | Available sizes | 100, 500, &1000 mg | 2x4 cm to 6x9 cm | 20 mg- 1000 mg | The available sizes for the subject device are in the range of the available sizes for the reference device. The sizes for the primary device are not applicable as it is not available in powder formulation | | How supplied | Powder; for single use | Single or double layered sheet; for single use | Powder, for single use | The subject device and reference device are both supplied in powder form and for single use. | | Biocompatible | Yes | Yes | Yes | Substantially Equivalent | {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ #### Performance Data Non-Clinical Test per 21 CFR 807.92(b)(1) No performance standards applicable to this device have been adopted under section 514 of The FD&C Act. Organogenesis Inc. has applied the use of voluntary standards to PuraPly® MZ, including current ISO standards for biocompatibility tests. PuraPly® MZ conforms to the requirements of the voluntary standards used. The following non-clinical battery of testing was performed: The subject device was evaluated for the following parameters: - . Color - Particle size ● - Differential Scanning Calorimetry (DSC) temperature ● - Absorption capacity . - Mixing ratio ● - Endotoxin levels ● - pH . #### Performance Data Conclusions per 21 CFR 807.92(b)(3) The subject device utilizes the same intended use, material composition, and similar technological characteristics as the predicate devices. The non-clinical laboratory data supports the subject device and the predicate device and demonstrates that any differences in technological characteristics do not raise any new questions of safety and effectiveness. Therefore, the subject device, PuraPly® MZ is substantially equivalent to the predicate devices identified throughout this submission. Below is a table that describes the biocompatibility study tests that were performed on the subject device, PuraPly® MZ. Based on the ISO10993-1 guidance for industry, the battery of tests included the following: - Cytotoxicity; ISO 10993-5 (2009) . - Sensitization; ISO 10993-10 (2010) . - Irritation; ISO 10993-10 (2010) . - Pyrogenicity; ISO 10993-11 (2017) . {11}------------------------------------------------ - Acute systemic Toxicity; ISO 10993-11 (2017) . - Sub-acute systemic toxicity/ Implantation; ISO 10993-6 (2016) and ISO 10993-11 (2017) . - Sub-chronic systemic toxicity; ISO 10993-6 (2016) and ISO 10993-11 (2017) • - Genotoxicity; ISO 10993-3 (2014) and ISO 10993-12 (2012) . - Large animal wound healing study; ISO 10993-6 (2016) • All tests were performed in compliance with ISO 10993-1, ISO 13485, and ISO 17025 standards, unless otherwise indicated specifically.