(126 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of surgical sutures, with no mention of AI or ML technology.
No.
The device is a surgical suture used for tissue approximation and ligation, which are procedures, not therapies.
No
The device description clearly states it is a surgical suture used for soft tissue approximation and/or ligation, which are therapeutic medical procedures, not diagnostic ones.
No
The device description explicitly states the device consists of physical components: absorbable polyglycolic acid or polydioxanone sutures and stainless steel needles. This indicates it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "general soft tissue approximation and/or ligation" and "all types of soft tissue approximation." This describes a surgical device used directly on the body for physical repair or joining of tissues.
- Device Description: The description details a "surgical suture" and a "stainless steel needle." These are physical tools used in surgical procedures.
- 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) to provide information for diagnosis, monitoring, or screening. The device is used on the body, not on a sample from the body.
IVD devices are used to perform tests in vitro (outside the body) on samples to gain diagnostic information. This device is used in vivo (inside the body) for surgical purposes.
N/A
Intended Use / Indications for Use
Absorbable polyglycolic acid suture with needle is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic, cardiovascular and neurological tissues.
Absorbable Polydioxanone Suture with Needle is indicated for use in all types of soft tissue approximation, including use in cardiovascular tissue where growth is expected to occur, PDO suture is not indicated in adult cardiovascular tissue, microsurgery, ophthalmic and neural tissue.
Product codes
GAM, NEW
Device Description
The applicant devices of absorbable polyglycolic acid suture with needle consist of a polyglycolic acid surgical suture made of polyglycolic acid and a stainless steel needle. It is EO sterilized, and prygon-free.
The applicant devices of absorbable polydioxanone suture with needle consist of a polydioxanone surgical suture made of polyester and a stainless steel needle. It is unbraided. It is EO sterilized, and prygon-free.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue, cardiovascular 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)
Physical testing was performed on the subject device to USP 30, including Suture Diameter, Suture Attachment, Tensile Strength. Biocompatibility studies were performed in accordance with ISO10993. In vivo strength test was also conducted on the subject device to demonstrate rates of tensile and mass loss.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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K073614 page 1/3
Premarket Notification 510(k) Submission -510(k) Summary Report No .: A20071012
APR 3 0 2008
510(k) Summary
As Required by 21 CFR 807.92
The Assigned 510(k) Number is: K073614
Submitter Information:
Manufacturer Name: Foosin Medical Supplies Inc., Ltd. No.312, Shichang Road Weihai, Shandong, China, 264209
Contact Person of the Submission: Ms. Diana Hong Mr. Eric Chen Shanghai Mid-Link Business Consulting Co., Ltd Suite 8D, Zhongxin Zhongshan Mansion, No.19, Lane 999, Zhong Shan Nan Er Road Shanghai, China 20020 Phone: +86-21-64264467 x 152 Fax: +86-21-64264468 x 809 Email: Diana.hong(@mid-link.net eric.chen(a)mid-link.net
Applicant Device Information
- Absorbable Polyglycolic Acid Suture with Needle
1.1 Applicant Device Information
Trade/Proprietary Name: WG-Surgical Sutures with Needle Common Name: Absorbable Polyglycolic Acid Suture with Needle Classification Name: Suture, Absorbable, Synthetic, Polyglycolic Acid Device Class: II Product Code: GAM Regulation Number: 878.4493 Review Panel: General & Plastic Surgery
Shanghai Mid-Link Business Consulting Co., Ltd
1
K073614 p
Premarket Notification 510(k) Submission -510(k) Summary Report No .: A20071012
Intended Use:
Absorbable polyglycolic acid suture with needle is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic, cardiovascular and neurological tissues.
1.2Predicate Device
K-number: K063536
1.3Device Description
The applicant devices of absorbable polyglycolic acid suture with needle consist of a polyglycolic acid surgical suture made of polyglycolic acid and a stainless steel needle. It is EO sterilized, and prygon-free.
1.4 Performance Data:
Physical testing was performed on the subject device to USP 30, including Suture Diameter, Suture Attachment, Tensile Strength. Biocompatibility studies were performed in accordance with ISO10993. In vivo strength test was also conducted on the subject device to demonstrate rates of tensile and mass loss.
1.5 Substantially Equivalence Determination
The applicant device of Absorbable Polyglycolic Acid Suture with Needle is substantially equivalent to the predicate device.
2. Absorbable Polyglycolic Acid Suture with Needle
2.1Applicant Device Information
Trade/Proprietary Name: WG-Surgical Sutures with Needle Common Name: Absorbable Polydioxanone Suture with Needle Classification Name: Suture, Absorbable, Synthetic, Polydioxanone Device Class: II Product Code: NEW Regulation Number: 878.4840 Review Panel: General & Plastic Surgery Intended Use:
Absorbable Polydioxanone Suture with Needle is indicated for use in all types of soft tissue approximation, including use in cardiovascular tissue where growth is expected to occur, PDO suture is not indicated in adult cardiovascular tissue, microsurgery, ophthalmic and neural tissue.
2.2Predicate Device
K-number: K053380
2
2.3Device Description
The applicant devices of absorbable polydioxanone suture with needle consist of a polydioxanone surgical suture made of polyester and a stainless steel needle. It is unbraided. It is EO sterilized, and prygon-free.
2.4 Performance Data:
Physical testing was performed on the subject device to USP 30, including Suture Diameter, Suture Attachment, Tensile Strength. Biocompatibility studies were performed in accordance with ISO10993. In vivo strength test was also conducted on the subject device to demonstrate rates of tensile and mass loss.
2.5 Substantially Equivalence Determination
The applicant device of Absorbable Polydioxanone Suture with Needle is substantially equivalent to the predicate device.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 2008
Foosin Medical Supplies, Inc. % Shanghai Midlink Business Consulting Co., Ltd. Ms. Diana Hong Suite 8D, Zhongxin Zhongshan Mansion No. 19, Lane 999, Zhong Shan No. 2 Road(S) Shanghai, China 200030
Re: K073614
Trade/Device Name: WG-Surgical Sutures with Needle Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: II Product Code: NEW, GAM Dated: April 4, 2008 Received: April 4, 2008
Dear Ms. Hong:
We have reviewed vour 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
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Page 2 - Ms. Diana Hong
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket survéillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: K073614
WG-Surgical Sutures with Needle Device Name:
Indications for Use:
Absorbable polyglycolic acid suture with needle is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic, cardiovascular and neurological tissues.
Absorbable Polydioxanone Suture with Needle is indicated for use in all types of soft tissue approximation, including use in cardiovascular tissue where growth is expected to occur, PDO suture is not indicated in adult cardiovascular tissue, microsurgery, ophthalmic and neural tissue.
Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nil Rr Ggl for AKm
(Division Sign-Off)
Page 1 of 1
Division of General, Restorative, and Neurological Devices
510(k) Number K073614