K Number

Device Name

SurgiAid® Collagen Wound Dressing

Manufacturer

Maxigen Biotech, Inc.

Date Cleared

2023-10-11

(373 days)

Product Code

KGN

Regulation Number

N/A

Intended Use

SurgiAid® Collagen Wound Dressing is indicated for use in patients who have surgical wounds, donor sites/grafts, podiatric wound, wound dehiscence, traumatic wounds, abrasions, lacerations, partial thickness burns or skin tears. SurgiAid® Collagen Wound Dressing can be applied to wounds with depth less than 0.3 cm.

Device Description

SurgiAid Collagen Wound Dressing (SurgiAid) is white, porous pliable and absorbable collagen wound dressing. It is fabricated by fibrous collagen matrix which is purified from bovine Achilles tendon. SurgiAid is pliable and can be applied easily to clean wound. The product is supplied in sterile, non-pyrogenic package, and is indicated for single use only.

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

K100927

Reference Devices

K122325

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a collagen wound dressing and its performance testing, with no mention of AI or ML.

Therapeutic

Yes
The device is a wound dressing applied to various types of wounds, which falls under the definition of a therapeutic device as it is intended to treat or manage a condition.

Diagnostic

Explanation: The device, SurgiAid® Collagen Wound Dressing, is intended for use in treating surgical wounds, burns, and skin tears, not for diagnosing medical conditions. Its function is to cover and protect wounds, not to identify or assess them.

SaMD (Software as a Medical Device)

The device description clearly states it is a physical wound dressing made from collagen, which is a hardware component.

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 SurgiAid® Collagen Wound Dressing is for the treatment of various types of wounds. This is a therapeutic application, not a diagnostic one.
Device Description: The description details a physical wound dressing made from collagen, designed to be applied directly to a wound. This is consistent with a therapeutic device.
Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples from the body (like blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition.
Performance Studies: The performance studies focus on biocompatibility, sterilization, packaging, and stability – all relevant to a therapeutic device applied to the body, not an IVD.

IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or screening purposes. SurgiAid® Collagen Wound Dressing is applied in vivo (on the body) for wound management.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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)

The following non-clinical performance test evaluation associated with physicochemical and microbial properties, biocompatibility, sterilization, packaging and stability were conducted on SurgiAid Collagen Wound Dressing (subject device). The Biocompatibility evaluations including cytotoxicity, genotoxicity, acute systemic toxicity, sub chronic systemic toxicity, irritation reactivity, sensitization and pyrogen for the subject device were in accordance with ISO10993-1:2018. All results were acceptable. Moreover, the evaluation of sterilization, product/packaging stability (packaging- burst test, creep test, seal strength, dye penetration and sterility) and product characteristics testing (dimension, bioburden, endotoxin, thermal characteristics, collagenase resistance heavy metal value, lipid, carbohydrate, pepsin resistance and pH) has been completed and these results were leveraged to demonstrate the substantial equivalence between the subject device and predicated device. All tests were met acceptance criteria in according with related standards.

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.

K100927

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.

K122325

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). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

October 11, 2023

Maxigen Biotech, Inc. Cheng-Han Chou Regulatory Affairs No. 88, Keji 1st Rd., Guishan District Taoyuan City, 333411 Taiwan

Re: K223126

Trade/Device Name: SurgiAid® Collagen Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: July 12, 2023 Received: July 13, 2023

Dear Cheng-Han Chou:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Yu-chieh Chiu -S

Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Indications for Use

510(k) Number (if known) K223126

Device Name SurgiAid Collagen Wound Dressing

Indications for Use (Describe)

SurgiAid Collagen Wound Dressing is indicated for use in patients who have surgical wounds, donor sites/grafts, podiatric wound, wound dehiscence, traumatic wounds, abrasions, partial thickness burns or skin tears. SurgiAid Collagen Wound Dressing can be applied to wounds with depth less than 0.3 cm.

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 (K223126)

Date of Summary revised: October 11, 2023

SUBMITTER TYPE INFORMATION : 1.

Name: Maxigen Biotech Inc. Address:No.88, Keji 1st Rd., Guishan Dist., Taoyuan City 333, Taiwan (R.O.C.) Phone:886-3-3287222 Fax:886-3-3287333 Contact:Cheng Han, Chou

2. DEVICE :

Name: SurgiAid Collagen Wound Dressing Common Name : Collagen Wound Dressing Classification Regulation/Class:Unclassified Product Code:KGN Panel:General & Plastic Surgery

PREDICATE DEVICE : 3.

Predicate device: SurgiAid Collagen Wound Dressing (K100927) Reference device: SkinTemp II Dressing (K122325)

4. DEVICE DESCRIPTION :

INDICATIONS FOR USE : 5.

COMPARISION OF TECHNOLOGICAL CHARACTERISTICS 6.

The subject device has the same characteristics as the predicate device in terms of raw materials, nature of sterile barrier system as well as sealing process, sterilization method, shelf-life, indication for use, operation and thickness of device. The different is identified in dimension of device and addition of eight new size in this submission. Please refer to Table 1 for comparison of the subject device and predicate device. The introduction of new dimensions in SurgiAid does not affect the intended use, performance test and fundamental scientific technology of the device.

Item	Subject Device	Predicate Device	Reference Device	Comparison
Manufacturer	MAXIGEN
BIOTECH INC.	MAXIGEN
BIOTECH INC.	Human
Biosciences,Inc.	Identical to
Predicate Device
510(k) No.	K223126	K100927	K122325	N/A
Product Code	KGN	KGN	KGN	Identical
Classification
name	Collagen Wound
Dressing	Collagen Wound
Dressing	Collagen Wound
Dressing	Identical
Indications for
use	SurgiAid® Collagen
Wound Dressing is
indicated for use in
patients who have
surgical wounds,
donor sites/grafts,
podiatric wound,
wound dehiscence,
traumatic wounds,
abrasions, lacerations,
partial thickness burns
or skin tears.
SurgiAid® Collagen
Wound Dressing can
be applied to wounds
with depth less than
0.3 cm	SurgiAid® Collagen
Wound Dressing is
indicated for use in
patients who have
surgical wounds,
donor sites/grafts,
podiatric wound,
wound dehiscence,
traumatic wounds,
abrasions, lacerations,
partial thickness burns
or skin tears.
SurgiAid® Collagen
Wound Dressing can
be applied to wounds
with depth less than
0.3 cm	The HBS
SkinTemp II
Dressing is
indicated for the
management of
burns, sores,
blisters, scrapes,
ulcers, and other
wounds.	Identical to
Predicate Device
Materials	Bovine (Achilles)
tendon type I collagen	Bovine (Achilles)
tendon type I collagen	Type I bovine
collagen	Identical to
Predicate Device
Form	Sheet	Sheet	Sheet	Identical
Specifications	15mm x 20mm x 0.5mm	20mm x 40mm x 3.0mm	2" x 2"	The sizes of
the subject
device
fall within the
size
range of the
reference device
	20mm x 30mm x 0.5mm	20mm x 30mm x 3.0mm	3" x 4"
	25mm x 30mm x 0.5mm		8" x 12"
	30mm x 40mm x 0.5mm
	100mm x 100mm x 0.5mm
	20mm x 40mm x 3.0mm
	30mm x 30mm x 3.0mm
	40mm x 50mm x 3.0mm
	50mm x 50mm x 3.0mm
	100mm x 100mm x 3.0mm
Usage type	Single use only	Single use only	Single patients use	Identical
Sterilization	By gamma irradiation	By gamma irradiation	Each dressing is
sterilized using
Electron Beam
Sterilization	Identical to
Predicate Device
Design	White, porous, pliable,
absorbable, sterile,
non-pyrogenic
package collagen
wound dressing and it
is indicated for single
use only.	White, porous, pliable,
absorbable, sterile,
non-pyrogenic
package collagen
wound dressing and it
is indicated for single
use only.	Soft, sterile,
disposable,
absorbent &
confirmable single
use wound dressing
with non-adherent
backing	Identical to
Predicate Device
Biocompatibility	All biocompatibility
evaluations of
SurgiAid were
conforms to the
requirements specified
in ISO10993	All biocompatibility
evaluations of
SurgiAid were
conforms to the
requirements specified
in ISO10993	All testing was
performed as per
FDA
biocompatibility
guidance on
ISO10993	Identical
Shelf life	Three years	Three years	Five years	Identical to
Predicate Device
Sterile Barrier
Packaging	Double blister tray as
Sterile Barrier System	Double blister tray as
Sterile Barrier System	It is packed in
primary packaging
in the form of a
Tyvek pouch
(1050B) and is then	Identical to
Predicate Device
			packed in
secondary packing
for additional
protection
Storage
condition	Store in a dry place
below 25°C	Store in a dry place
below 25°C	Store in a cool and
dry place	Identical to
Predicate Device
Performance	● Water absorption
(>25 fold)	● Water absorption
(>25 fold)	NA	Identical to
Predicate Devic
	● Porosity (>80%)	● Porosity (>80%)
	● Density (About 37
mg/cm³)	● Density (About 37
mg/cm³)

Table 1. Substantial Equivalence Comparison of SurgiAid Collagen Wound Dressing of the predicate device.

7. NON-CLINICAL PERFORMANCE DATA:

The subject device is technically identical to the predicate device regarding materials, indications for use, form, sterilization, packaging and storage conditions. The only difference is the addition of new dimension. Any potential new risks raised with the new dimension have been identified and addressed with verification and validation activities to ensure that substantial equivalence is still established in technological characteristics.

The following non-clinical performance test evaluation associated with physicochemical and microbial properties, biocompatibility, sterilization, packaging and stability were conducted on SurgiAid Collagen Wound Dressing (subject device). The subject device is comprised of the same materials and undergo the same manufacturing process as the predicate device but different in dimensions simply caused by physical cutting.

The Biocompatibility evaluations including cytotoxicity, genotoxicity, acute systemic toxicity, sub chronic systemic toxicity, irritation reactivity, sensitization and pyrogen for the subject device were in accordance with ISO10993-1:2018. All results were acceptable. Moreover, the evaluation of sterilization, product/packaging stability (packaging- burst test, creep test, seal strength, dye penetration and sterility) and product characteristics testing (dimension, bioburden, endotoxin, thermal characteristics, collagenase resistance heavy metal value, lipid, carbohydrate, pepsin resistance and pH) has been completed and these results were leveraged to demonstrate the substantial equivalence between the subject device and predicated device. All tests were met acceptance criteria in according with related standards.

Conclusion 8.

SurgiAid Collagen Wound Dressing (subject device) has the same fundamental scientific technology and indications for use as the originally cleared SurgiAid (predicate device) in terms of product's designs, biocompatibility, raw material used, manufacturing process, primary composition, performance, packaging and sterilization method based on declaration of conformity to pre-established design control requirements and on a risk assessment of the changes to predicate device. The only modification for the subject device is the addition of new dimensions to the predicate device that is also derived from the same component material. Existing biocompatibility, sterilization validation and stability test performed on predicated device could be leveraged without affecting safety and efficacy of subject device. No additional new risk with respect to safety and efficacy of subject device is identified in the course of introduction of new dimensions. Consequently, SugiAid Collagen Wound Dressing (subject device) is substantially equivalent to the predicate SurgiAid cleared under K100927.