The provided text describes a 510(k) premarket notification for a medical device called "Omega V L," an absorbable polydioxanone surgical suture. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove the device meets specific performance acceptance criteria for a new medical device. The information required in the prompt is not fully available in the provided text.

Here's an analysis of the available information in relation to your questions, and what is not provided:

1. A table of acceptance criteria and the reported device performance

Not provided in this document directly as acceptance criteria for this device. The document states that the device is "substantially equivalent" to the predicate device in its "performance properties." It lists non-clinical studies (biocompatibility and bench testing) but does not present specific acceptance criteria values the Omega V L device needed to meet, nor does it provide a table of measured performance values for the Omega V L device against such criteria. Instead, it implies that by performing these tests, the device's performance is comparable to the predicate.

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

Not provided. The document lists types of tests (e.g., Biocompatibility, USP <861> Sutures—Diameter, USP <881> Tensile Strength, Barb Holding Strength, In Vitro Resorption Rate Test, In Vitro Tensile Strength Test) but does not specify the sample sizes used for these tests. Data provenance details are also not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable / Not provided. For a surgical suture, the "ground truth" for performance is typically established through direct physical and chemical measurements (e.g., tensile strength, diameter, absorption rate) rather than expert consensus on interpretation, as might be the case for an imaging AI device. Therefore, a "ground truth" established by experts in the sense of adjudicating findings is not relevant here, and no such information is provided.

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

Not applicable / Not provided. As mentioned above, performance of a suture is determined by objective measurements, not by expert adjudication of interpretations.

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 surgical suture, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant.

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

Not applicable. This device is a surgical suture, not an algorithm.

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

For the non-clinical studies listed, the "ground truth" would be the objective measurements obtained from physical, chemical, and biological testing as per ISO and USP standards (e.g., measured diameter, tensile strength, cytotoxicity, irritation, etc.). There is no mention of expert consensus, pathology, or outcomes data being used to establish a ground truth for the performance parameters.

8. The sample size for the training set

Not applicable / Not provided. This is a physical medical device (suture), not an AI algorithm that requires a training set.

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

Not applicable / Not provided. As above, no training set for an algorithm is involved.

In summary of what is available:

The document focuses on demonstrating substantial equivalence of the Omega V L suture to a legally marketed predicate device (K130191 MINT). The basis for this equivalence is stated to be:

Identical indications for use.
Similar technological characteristics (material, sterilization, suture type, deployment technique, barbs, absorbability, patient contact duration, color additive, suture diameters, tensile strength).
Non-clinical studies (biocompatibility and bench performance tests) conducted according to established international standards (ISO 10993 series) and U.S. Pharmacopeia (USP) standards to ensure safety and performance comparable to the predicate.

The specific numerical acceptance criteria and reported performance values against those criteria for the Omega V L are not explicitly presented as a table in this summary document. The assumption is that successful completion of the listed tests implies performance within an acceptable range, demonstrating equivalence to the predicate.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 2, 2018

Ov World Co., Ltd % Ho Dong Yang CEO Onbix Corporation #821 Samil Plaza, 837 -26 Yeuksam-dong Gangnam-gu, Seoul, South Korea 135-768

Re: K162366

Trade/Device Name: Omega V1 Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: Class II Product Code: NEW Dated: December 20, 2017 Received: January 3, 2018

Dear Ho Dong Yang:

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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162366

Device Name Omega V L

Indications for Use (Describe)

Omega V L comprised of PDO is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.

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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510(k) SUMMARY

This information is being submitted in accordance with the requirements of 21 CFR §807.92.

Submitter Information:	OV World Co., Ltd.(Gasan-dong, Fomatec Bd.) A-202, 213 205-28Gasan digital 1-ro, Geumcheon-gu, Seoul, Korea
Contact Person:	Ho Dong, YangOnbix Corporation#821 Samil Plaza, 14 Dogok-ro 1gil, 14Gangnam-gu, Seoul, 06253, KoreaTel: 82-2-566-3360 / Fax: 82-2-6280-3360Email: onbix@naver.com
Date Summary Prepared:	Feb 15, 2018
Device Information:

Trade Name(s):	Omega V L
Classification Name:	suture, absorbable, polydioxanone
Panel:	general & plastic surgery
Product code:	NEW

Predicate Device Information:

K130191 MINT (Hansbiomed Corporation)

Device Description:

This device is made of polydioxanone and has bi-directional barbs along the long axis of the suture monofilament without needle attachment

Indications for Use

Omega V L comprised of PDO is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.

Comparison to Predicate Device(s):

This device is equivalent to the predicate devices in its intended use and technological characteristics, including:

- indications for use
- technological characteristics
- performance properties

Summary of the technological characteristics compared to the predicate device

The device is substantially equivalent to the predicate device in its technological characteristics stated in the comparison table provided below.

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Comparison table is as follows:

Features	Omega V L	MINT
510(k) number	K162366	K130191
ProductClassification	Absorbable polydioxanonesurgical	Absorbable polydioxanonesurgical suture
Manufacturer	OV World Co., Ltd	Hansbiomed Corporation
Intended use	general soft tissue approximationwhere use of an absorbablesuture is appropriate	general soft tissue approximationwhere use of an absorbablesuture is appropriate
Sterilization	EO gas	EO gas
Raw Material	PDO (supplier: Samyang)	PDO
SutureCharacteristic	Synthetic AbsorbableMonofilament	Synthetic AbsorbableMonofilament
Technique ofDeployment	Needles are not attached	Needles are not attached
Technicalcharacteristic	Bi-directional barbs along the longaxis of the suture monofilamentwithout needle attachment	Bi-directional barbs along the longaxis of the suture monofilamentwithout needle attachment
Absorbable	Absorbable	Absorbable
Patient contact	Implant	Implant
Duration contact	Over 30 days	Over 30 days
Color additive	D&C Violet No.2	D&C Violet No.2
Suture diameters(USP)	1	1
Tensile strength	USP 2-0	USP 2-0

Non-Clinical Study Performance

Biocompatibility testing

Test	Method
Cytotoxicity	ISO 10993-5
Sensitization	ISO 10993-10
Acute Systemic Toxicity	ISO 10993-11
Irritation (Intracutaneous Reactivity)	ISO 10993-10
Material Mediated Pyrogenicity	ISO 10993-11
Mammalian Erythrocyte Micronucleus Test	ISO 10993-3
In Vitro Chromosomal Aberration Test	ISO 10993-3

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Test	Method
Bacterial Reverse Mutation (Ames Test)	ISO 10993-3
Subchronic Systemic Toxicity	ISO 10993-11
Implantation	ISO 10993-6
Hemolysis	ISO 10993-4
LAL Endotoxin Test	USP <85>

Bench (performance) testing

Test
Absorption Test (non-barbed suture)
USP <861> Sutures—Diameter
USP <881> Tensile Strength
Barb Holding Strength
In Vitro Resorption Rate Test
In Vitro Tensile Strength Test

Conclusion

Based on the information provided in this summary, we conclude that Omega V L is substantially equivalent to the predicate device K130191.

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.