Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the material properties and biological effects of a collagen-based wound matrix, with no mention of AI or ML technologies.

Therapeutic

Yes
The text explicitly states that the device is "intended for the management of wounds," which implies a therapeutic purpose.

Diagnostic

No
The device is described as a wound matrix for the management of various wounds, indicating it is intended for treatment rather than diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of "micronized porcine collagen" and is supplied as a "dry powder." This indicates a physical material, not software.

IVD (In Vitro Diagnostic)

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 wounds." This involves applying the material directly to the wound for therapeutic purposes.
Device Description: The device is described as a "micronized porcine collagen intended for the management of wounds." It's a physical material applied to the body.
Lack of Diagnostic Purpose: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Performance Studies: The performance studies focus on the physical and biological properties of the material itself (particle size, absorption, biocompatibility, wound healing in animals), not on its ability to detect or measure substances in a biological sample.

IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes. PuraPly® Micronized Wound Matrix is applied in vivo (on the body) for wound management.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

KGN

Device Description

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 $\le$ 1000μm. The device is sterile and packaged in a vial sealed in a single pouch.

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

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)

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

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)
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.

Key results: 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.

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.

K011026

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.

K172399

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

Regulation Number and Section

N/A

Summary

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)

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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.

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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.