The PDS Barbed Surgical Suture is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate. The anatomical location(s) of use are on the skin for dermatological applications only. The suture is not intended for interior body cavity applications and the suture is not intended for lifting and supporting tissues.

Device Description

PDO MAXX THREADS™ barbed sutures are made of polydioxanone (PDO) and have the colorant D&C Violet No. 2 (21 CFR 74.3602). The sutures are USP 0 suture in diameter and USP 2-0 suture in tensile strength, and 150 mm in length, swaged to a 19G/100 mm "L" Blunt needle and preloaded in a needle cannula. The sutures are inserted into the cannula/needle. The barbed sutures have cut barbs along the axis of the monofilament that allows the suture to embed in the tissue after the surgeon has placed it; therefore, there is no need to tie a surgical knot. The sutures are absorbable in the body.

AI/ML Overview

The provided text describes the 510(k) summary for the PDO MAXX Threads Barbed Suture, focusing on its substantial equivalence to a predicate device. It details biocompatibility and performance testing, but it does not include information typically found in studies designed to establish acceptance criteria for AI/ML-driven medical devices.

Therefore, many of the requested categories cannot be populated from the provided text. The device in question is a surgical suture, not an AI/ML diagnostic or therapeutic device.

Here's a breakdown based on the provided text, with explicit notes for information that cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility:
- Cytotoxicity	Met (implied by "support of the substantial equivalence determination")
- Irritation	Met (implied)
- Acute Systemic	Met (implied)
- Material Mediated Pyrogenicity	Met (implied)
- Genotoxicity, Carcinogenicity, and Reproductive Test	Met (implied)
- Endotoxin	Met (implied)
- Sensitization	Met (implied)
Needle Biocompatibility:
- Cytotoxicity	Met (implied)
- Acute Systemic	Met (implied)
- Material Mediated Pyrogenicity	Met (implied)
- Intracutaneous Reactivity Test	Met (implied)
- Skin Sensitization Test	Met (implied)
- Hemolysis Test	Met (implied)
Suture Performance:
- Suture Absorption	Data provided (implied, "Suture Absorption" is a test)
- Dimension Test	Data provided (implied, "Dimension Test" is a test)
- Tensile Strength	Data provided (implied, "Tensile Strength" is a test), specifically USP 2-0 tensile strength.
Needle Performance:
- Inner/Outside Structure	Data provided (implied)
- Dimension Test	Data provided (implied)
- Elasticity Test	Data provided (implied)
- Flexural Rigidity Test	Data provided (implied)
- Draw Test	Data provided (implied)
- Extraction Test	Data provided (implied)
In Vivo Biodegradation:
- Absorption and Tensile Strength over time in Sprague-Dawley Rat	Data provided (implied)

Note: The document states "The following performance data were provided in support of the substantial equivalence determination," implying that the device met the necessary criteria for each test. Specific numerical performance values or explicit acceptance criteria (e.g., "tensile strength must be X N") are not detailed in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable in the context of an AI/ML algorithm. For the in vivo animal study, the sample size is not specified but involved Sprague-Dawley Rats. For other performance tests, standard industry-specific sample sizes would have been used, but are not detailed here.
Data Provenance: Not specified, but laboratory and animal testing are typically conducted under controlled conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable as this is not an AI/ML diagnostic or image analysis device that requires expert ground truth labeling.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical surgical suture, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a physical surgical suture.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the physical and material properties, the "ground truth" would be established by validated scientific and engineering testing methods and standards (e.g., ISO standards for biocompatibility, USP standards for sutures, internal validation protocols). For the in vivo study, the ground truth is the measured absorption and tensile strength in live animal models.

8. The sample size for the training set

Not applicable. This device is a physical surgical suture, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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June 4, 2019

PDO MAX, Inc. % Ms. Mary Vater Regulatory Consultant Medical Device Academy, Inc. 345 Lincoln Hill Rd. Shrewsbury, Vermont 05738

Re: K190245

Trade/Device Name: PDS Barbed Suture, PDO MAXX Threads Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: Class II Product Code: NEW Dated: March 6, 2019 Received: March 6, 2019

Dear Ms. Vater:

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.

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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.

For David Krause, Ph.D. Acting Division Director Division of Infection Control and Plastic Surgery Devices Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190245

Device Name

PDO MAXX Threads Barbed Surgical Suture

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

K190245 pg. 1 of 3

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:

SUBMITTER 1. PDO Max, Inc. 4971 Bear Road Liverpool. New York 13088 Tel: +1.315.708.9913

Contact Person:	Giovanna McCarthy
Date Prepared:	4 February 2019

II. DEVICE Name of Device: PDO MAXX Threads Barbed Suture Classification Name: Suture, Surgical, Absorbable, Polydioxanone Regulation: 21 CFR §878.4840 Regulatory Class: Class II Product Classification Code: NEW
III. PREDICATE DEVICE

Predicate Manufacturer:	Feeltech Co., Ltd.
Predicate Trade Name:	Miracu
Predicate 510(k):	K172602

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

The suture is not intended for interior body cavity applications and the suture is not intended for lifting and supporting tissues.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVCE

The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:

. Indications for Use – The predicate and subject device have almost indications for use; both are indicated for use in soft tissue approximation where use of absorbable sutures is appropriate,

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K190245 pg. 2 of 3

specifically designed for use in the skin.

. Materials - The predicate and subject device materials are identical.
. Design - The predicate and subject device are equivalent in design. They are both made of the same basic monofilament with similar barbs cut into the monofilament. Both the predicate and subject devices are supplied to the user pre-loaded in a hollow needle.
Energy Source Neither the predicate nor the subject device requires an energy source. ●
Performance Testing - Both the predicate and subject devices were subjected to the same biocompatibility and performance tests listed below.

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Suture Biocompatibility Testing

· Cytotoxicity
· Irritation
· Acute Systemic
· Material Mediated Pyrogenicity
· Genotoxicity, Carcinogenicity, and Reproductive Test
Endotoxin
· Sensitization

Needle Biocompatibility Testing

· Cytotoxicity
· Acute Systemic
· Material Mediated Pyrogenicity
· Intracutaneous Reactivity Test
· Skin Sensitization Test
· Hemolysis Test

Suture Performance Testing

· Suture Absorption
· Dimension Test
· Tensile Strength

Needle Performance Testing

Inner/Outside Structure
· Dimension Test
· Elasticity Test
· Flexural Rigidity Test
Draw Test
· Extraction Test

Electrical Safety and EMC Testing

Electrical safety and EMC testing were not applicable.

Animal Testing

In Vivo Biodegradation in Sprague-Dawley Rat Absorption and Tensile Strength over . time

Clinical Testing

Clinical testing was not required to demonstrate the safety and effectiveness.

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K190245 pg. 3 of 3

VIII. CONCLUSIONS

Based on a comparison of technological characteristics, indications for use, and performance data, it can be concluded that the proposed PDS Barbed Suture is substantially equivalent to the predicate device.

Regulation Number and Section

§ 878.4840 Absorbable polydioxanone surgical suture.

(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.