K Number

Device Name

FortiShield (Biosynthetic Wound Matrix)

Manufacturer

Organogenesis Inc.

Date Cleared

2023-05-02

(624 days)

Product Code

KGN

Regulation Number

N/A

Intended Use

FortiShield is intended for use as a temporary wound covering, and to provide a moist wound healing environment on cleanly debrided wounds after hemostasis has been established. FortiShield is indicated for: partial thickness wounds, pressure sores, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears) and draining wounds.

Device Description

FortiShield is a sterile, translucent biosynthetic wound matrix made from a knitted tri-filament nylon fabric that is mechanically bonded to a semi-permeable silicone membrane. Denatured porcine dermal collagen is bonded to the nylon/silicone bi-layer membrane to provide a dressing that is designed to adhere to the application site, provide a barrier to the external environment, and allow for excess exudate drainage. FortiShield is not made with natural rubber latex. FortiShield is non-pyrogenic.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

AWBAT (K082869), Biobrane II (K901369), PermeaDerm B (K153678)

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical wound dressing and does not mention any computational or analytical capabilities that would suggest the use of AI/ML.

Therapeutic

Yes.
The device is indicated for various types of wounds, including partial thickness wounds, pressure sores, and ulcers, and provides a moist wound healing environment, which are therapeutic actions.

Diagnostic

No
The device is described as a temporary wound covering that provides a moist healing environment and acts as a barrier. Its indications for use are for various types of wounds, and its mechanism is described as physical adherence and protection. There is no mention of diagnostic capabilities, such as disease detection, imaging, or analysis of bodily functions.

SaMD (Software as a Medical Device)

The device description clearly states that FortiShield is a physical wound matrix made from nylon fabric, silicone membrane, and collagen. It is a tangible, physical medical device, 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 FortiShield is a "temporary wound covering" and is used to "provide a moist wound healing environment." This is a therapeutic function applied directly to the body, not a diagnostic test performed on a sample taken from the body.
Device Description: The description details a physical wound dressing made of nylon, silicone, and collagen. This aligns with a medical device used for wound management, not a diagnostic reagent or instrument.
Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
Performance Studies: The performance studies focus on mechanical properties and biocompatibility, which are relevant to a wound dressing, not a diagnostic device.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. FortiShield's function is to cover and protect wounds and promote healing, which falls under the category of a therapeutic medical device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

FortiShield is indicated for: partial thickness wounds, pressure sores, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears) and draining wounds.

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

KGN

Device Description

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)

Non-Clinical Mechanical Testing: Mechanical testing conducted on the FortiShield device and the Biobrane II predicate device demonstrates that the following performance properties of the devices are equivalent: tensile elongation, fatigue, and water vapor transmission rate.

Biocompatibility Testing: FortiShield was determined to be biocompatible based on ISO 10993-1 and "FDA General Guidance on Biological Evaluation of Medical Devices- Part 1: Evaluation and testing within a risk management process." Based on the intended use of FortiShield, the device is classified according to ISO 10993-1 as a surface device with prolonged (>24 hours to 30 days) contact with breached, compromised surfaces. The following biological endpoints were included in the evaluation of the biological safety of FortiShield: irritation or intracutaneous reactivity, acute systemic toxicity, implantation, cytotoxicity, genotoxicity, hemolysis, material-mediated pyrogenicity, and chemical characterization (extractables) with toxicological risk assessment. The tests and chemical characterization were performed on the final, finished and sterile subject device and the device is considered to be biocompatible based on these results.

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.

AWBAT (K082869), Biobrane II (K901369), PermeaDerm B (K153678)

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.

Not Found

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

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.

May 2, 2023

Organogenesis Inc. Christina Nichols Program Manager, Regulatory Affairs 150 Dan Rd Canton, Massachusetts 02021

Re: K212579

Trade/Device Name: FortiShield (Biosynthetic Wound Matrix) Regulatory Class: Unclassified Product Code: KGN Dated: November 22, 2022 Received: November 22, 2022

Dear Christina Nichols:

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 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.

David Krause -S

for 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

Indications for Use

510(k) Number (if known) K212579

Device Name FortiShield™ Biosynthetic Wound Matrix

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary – K212579 - FortiShieId™ (Biosynthetic Wound Matrix)

Date Prepared:

May 2, 2023

Submitted By:

Organogenesis Inc. 150 Dan Rd Canton, MA 02021

Contact:

Name:	Christina Nichols
Title:	Associate Director of Regulatory Affairs
Telephone:	(781) 577-6065
Email:	CNichols@organo.com

Device:

| Trade Name: | FortiShield™
(Biosynthetic Wound Matrix) |
|----------------------|---------------------------------------------|
| Common Name: | Wound Dressing |
| FDA Product Code: | KGN |
| Classification Name: | Dressing, wound, collagen |
| 510(k) Number: | K212579 |

Predicate Devices:

The device is substantially equivalent to the following predicate devices:

Primary Predicate:	AWBAT (K082869)
Other Predicates:	Biobrane II (K901369) and PermeaDerm B (K153678)

Device Description:

dressing that is designed to adhere to the application site, provide a barrier to the external environment, and allow for excess exudate drainage.

FortiShield is not made with natural rubber latex. FortiShield is non-pyrogenic.

Intended Use:

FortiShield is intended for use as a temporary wound covering, and to provide a moist wound healing environment on cleanly debrided wounds after hemostasis has been established.

Indications for Use:

FortiShield is indicated for: partial thickness wounds, pressure sores, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears) and draining wounds.

Technological Characteristics and Performance Data (Predicate Comparison):

The device has equivalent design, intended use, material performance, and biocompatibility compared to the predicate devices.

The device has equivalent non-clinical performance as the predicate devices. Tensile elongation, water vapor transmission rate, and fatigue properties have been demonstrated as equivalent between the AWBAT predicate device.

A comparison of technological characteristics and performance data to the predicate devices is provided in Table 1, below.

	Subject Device	Predicate Devices
Characteristic	Organogenesis
Inc.
FortiShieldTM	Aubrey, Inc.
AWBAT-S,
AWBAT-D,
AWBAT-M
(Primary
Predicate)	Sterling Drug, Inc.
Biobrane II
(Other Predicate)	PermeaDerm, Inc.
Permeaderm B
and Permeaderm
CW
(Other Predicate)	Comparison
510(k)	K212579	K082869	K901369	K153678	N/A
FDA Product
Code	KGN	KGN	FRO	FRO	The FDA
product code
is identical to
the primary
predicate.
Principles of
Operation	Device covers the
wound to provide a
moist wound
environment and
allows the passage
of exudate.	Devices
covers the
wound to
provide a
moist wound
environment
and allows the
passage of
exudate.	Devices covers the
wound to provide a
moist wound
environment and
allows the passage
of exudate.	Devices covers the
wound to provide a
moist wound
environment and
allows the passage
of exudate.	Equivalent to
predicate
devices.
	Subject Device		Predicate Devices
	Organogenesis
Inc.	Aubrey, Inc.	Sterling Drug, Inc.	PermeaDerm, Inc.
Characteristic	FortiShield™	AWBAT-S,
AWBAT-D,
AWBAT-M	Biobrane II
(Other Predicate)	Permeaderm B
and Permeaderm
CW
(Other Predicate)	Comparison
		(Primary
Predicate)
Materials and
Structure	Porous Silicone
and Nylon Knit Bi-
layer Scaffold with
Cross-Linked
Collagen Coating	Porous
Silicone and
Nylon Knit Bi-
layer Scaffold
with Collagen
Coating	Porous Silicone and
Nylon Knit Bi-layer
Scaffold with Cross-
Linked Collagen
Coating	Porous Silicone and
Nylon Knit Bi-layer
Scaffold with
Collagen and Aloe
Coating	Equivalent to
predicate
devices. The
construction is
equivalent to
the primary
predicate and
the same as
the Biobrane II
predicate.
Indications
for Use	FortiShield is
indicated for: partial
thickness wounds,
pressure sores,
venous ulcers,
diabetic ulcers,
chronic vascular
ulcers, surgical
wounds (donor
sites/grafts, post-
Moh's, post-laser
surgery, podiatric,
wound
dehiscence),
trauma wounds
(abrasions,
lacerations, partial	Temporary
wound
dressing for
coverage of
Superficial
burns, Donor
sites and
Meshed
autographs.
AWBAT-S: is
intended for
clean
Superficial
burn wounds.	Covering donor
sites, clean,
debrided, or
excised superficial
and medium depth
partial (2°)
thickness wounds
and as a protective
covering over
meshed autografts.
Suggested Uses:
To manage clean
partial thickness
wounds	PermeaDerm B is
indicated for partial
thickness burn
wounds, donor sites
and coverage of
meshed autograft.
PermeaDerm CW is
indicated for partial
thickness wounds,
pressure sores,
venous ulcers,
diabetic ulcers,
chronic vascular
ulcers, surgical
wounds (donor
sites/grafts, post-	Equivalent to
predicate
devices. The
indicated
applications
are identical to
PermeaDerm
CW.
	Subject Device
Organogenesis
Inc.
FortiShield™	Aubrey, Inc.
AWBAT-S,
AWBAT-D,
AWBAT-M
(Primary
Predicate)	Predicate Devices
Sterling Drug, Inc.
Biobrane II
(Other Predicate)	PermeaDerm, Inc.
Permeaderm B
and Permeaderm
CW
(Other Predicate)	Comparison
Characteristic
	thickness burns,
and skin tears) and
draining wounds.	AWBAT-D: is
intended for
Donor sites
after
hemostasis
has been
established.
AWBAT-M: is
intended to be
used as a
protective
covering for
Meshed
autografts.	For wet wound
management to
minimize fluid
accumulation
For use in
situations where
maximum passage
of transudate is
desired	Moh's, post-laser
surgery, podiatric,
wound dehiscence,
trauma wounds
(abrasions,
lacerations,
second-degree
burns, and skin
tears) and draining
wounds.
Device
Dimensions	2" x 2" through 15"
x 30"	Unknown	2.5" x 5"
5" x 5"
5" x 7.5"
5" x 15"
10" x 15"	Permeaderm B:
5"x10
10"x15"
15"x30"
Permeaderm: CW
2.5" x 5"
5" x 5"	Equivalent to
predicate
devices. The
range of sizes
is within the
maximum size
offered for the
predicate
devices.
Sterility	Sterile, SAL 10-6	Sterile	Sterile	Sterile, SAL 10-6	Equivalent to
predicate
	Subject Device	Predicate Devices
	Organogenesis
Inc.
FortiShield™	Aubrey, Inc.
AWBAT-S,
AWBAT-D,
AWBAT-M
(Primary
Predicate)	Sterling Drug, Inc.
Biobrane II
(Other Predicate)	PermeaDerm, Inc.
Permeaderm B
and Permeaderm
CW
(Other Predicate)	Comparison
Characteristic
Pyrogenicity	Non-pyrogenic	Unknown	Non-pyrogenic	Unknown	devices. All devices are provided sterile.
Equivalent to predicate devices. Both the subject and primary predicate devices are non-pyrogenic.
Bio-
compatibility	Biocompatible	Biocompatible	Biocompatible	Biocompatible	Equivalent to predicate devices. All devices are deemed biocompatible based on ISO 10993 testing for their intended nature and
Characteristic	Subject Device
Organogenesis
Inc.
FortiShield™	Predicate Devices			Comparison
		Aubrey, Inc.
AWBAT-S,
AWBAT-D,
AWBAT-M
(Primary
Predicate)	Sterling Drug, Inc.
Biobrane II
(Other Predicate)	PermeaDerm, Inc.
Permeaderm B
and Permeaderm
CW
(Other Predicate)	duration of
contact.

Table 1: Comparison to Predicate Devices

Non-Clinical Mechanical Testing:

Mechanical testing conducted on the FortiShield device and the Biobrane II predicate device demonstrates that the following performance properties of the devices are equivalent: tensile elongation, fatigue, and water vapor transmission rate.

Biocompatibility Testing:

FortiShield was determined to be biocompatible based on ISO 10993-1 and "FDA General Guidance on Biological Evaluation of Medical Devices- Part 1: Evaluation and testing within a risk management process." Based on the intended use of FortiShield, the device is classified according to ISO 10993-1 as a surface device with prolonged (>24 hours to 30 days) contact with breached, compromised surfaces.

The following biological endpoints were included in the evaluation of the biological safety of FortiShield: irritation or intracutaneous reactivity, acute systemic toxicity, implantation, cytotoxicity, genotoxicity, hemolysis, material-mediated pyrogenicity, and chemical characterization (extractables) with toxicological risk assessment. The tests and chemical characterization were performed on the final, finished and sterile subject device and the device is considered to be biocompatible based on these results.

Conclusions:

The subject device and the predicate devices underwent evaluation that confirms equivalence in the intended use of each device, biocompatibility, performance, environment of use, and the principles of operation. Therefore, the subject device demonstrates substantial equivalence to the predicate devices.