(556 days)
Not Found
No
The summary describes a physical suture device and its performance testing, with no mention of AI, ML, image processing, or data sets typically associated with AI/ML technologies.
Yes
The device is described as "suture monofilament" used for "soft tissue approximation," which is a common medical procedure for repairing tissues in the body. This falls under the definition of a therapeutic device as it is intended to treat a condition (e.g., a wound or incision) by holding tissues together to facilitate healing.
No
Explanation: The device description indicates it is a suture monofilament used for soft tissue approximation, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is made of polydioxanone and has physical barbs, indicating it is a physical suture, not a software-only device. The performance studies also focus on physical properties and biocompatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "soft tissue approximation where use of absorbable sutures is appropriate." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a suture made of polydioxanone with barbs. This is a physical implantable device used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVDs are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
Omega V L comprised of PDO is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.
Product codes (comma separated list FDA assigned to the subject device)
NEW
Device Description
This device is made of polydioxanone and has bi-directional barbs along the long axis of the suture monofilament without needle attachment
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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 Study Performance
-
Biocompatibility testing
Tests performed: Cytotoxicity, Sensitization, Acute Systemic Toxicity, Irritation (Intracutaneous Reactivity), Material Mediated Pyrogenicity, Mammalian Erythrocyte Micronucleus Test, In Vitro Chromosomal Aberration Test, Bacterial Reverse Mutation (Ames Test), Subchronic Systemic Toxicity, Implantation, Hemolysis, LAL Endotoxin Test.
Methods: ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-3, ISO 10993-6, ISO 10993-4, USP . -
Bench (performance) testing
Tests performed: Absorption Test (non-barbed suture), USP Sutures—Diameter, USP Tensile Strength, Barb Holding Strength, In Vitro Resorption Rate Test, In Vitro Tensile Strength Test.
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.
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
§ 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.
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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
1
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, 213 205-28
Gasan digital 1-ro, Geumcheon-gu, Seoul, Korea |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ho Dong, Yang
Onbix Corporation
#821 Samil Plaza, 14 Dogok-ro 1gil, 14
Gangnam-gu, Seoul, 06253, Korea
Tel: *82-2-566-3360 / Fax: *82-2-6280-3360
Email: 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 |
| Product | ||
| Classification | Absorbable polydioxanone | |
| surgical | Absorbable polydioxanone | |
| surgical suture | ||
| Manufacturer | OV World Co., Ltd | Hansbiomed Corporation |
| Intended use | general soft tissue approximation | |
| where use of an absorbable | ||
| suture is appropriate | general soft tissue approximation | |
| where use of an absorbable | ||
| suture is appropriate | ||
| Sterilization | EO gas | EO gas |
| Raw Material | PDO (supplier: Samyang) | PDO |
| Suture | ||
| Characteristic | Synthetic Absorbable | |
| Monofilament | Synthetic Absorbable | |
| Monofilament | ||
| Technique of | ||
| Deployment | Needles are not attached | Needles are not attached |
| Technical | ||
| characteristic | Bi-directional barbs along the long | |
| axis of the suture monofilament | ||
| without needle attachment | Bi-directional barbs along the long | |
| axis of the suture monofilament | ||
| without 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 |
- Bench (performance) testing
| Test |
|---|
| Absorption Test (non-barbed suture) |
| USP Sutures—Diameter |
| USP 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.