(202 days)
Not Found
No
The description focuses on the material and physical properties of a surgical suture and does not mention any software, algorithms, or data processing capabilities that would indicate AI/ML.
No
This device is a surgical suture used for approximating soft tissues, which is a tool for enabling healing rather than actively providing therapy.
No
The device is an absorbable synthetic suture, which is used for soft tissue approximation. It is a therapeutic device, not a diagnostic one.
No
The device description clearly describes a physical medical device (suture with needle attachment) made of synthetic absorbable material. There is no mention of software as the primary component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general soft tissue approximation including ophthalmic surgery." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "synthetic absorbable suture with needle attachment." This is a physical material used to close wounds or hold tissues together during surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The description clearly indicates a surgical device used in vivo (within the living body), not an in vitro (in glass/outside the body) diagnostic test.
N/A
Intended Use / Indications for Use
Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) is indicated for use in general soft tissue approximation including ophthalmic surgery. Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) is not indicated for cardiovascular and neurological tissue approximation.
Product codes (comma separated list FDA assigned to the subject device)
GAM
Device Description
Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) is a synthetic absorbable suture based on Polyglycolic acid. Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) coated with polycaprolactone and calcium stearate, has been found to be inert, non-antigenic and nonpyrogenic. Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) are available dyed (violet) and undyed. Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) complies with the requirements of USP and EP.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue, ophthalmic
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)
Not Found
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
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this 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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SEP - 4 2008
Image /page/0/Picture/1 description: The image shows a logo with the text "JINHUAN Medical Products". To the left of the text is a circular symbol with two needle-like objects pointing upwards. The text "JINHUAN" is in a bold, sans-serif font, and "Medical Products" is in a smaller, regular font. The logo appears to be for a medical company or product line.
Shanghai Pudong Jinhuan Medical Products Co., Lt 25 Lianzhen Road, Pudong New Area, Shanghai 201204, P.R.CHINA. TEL: 021-50910082 FAX: 021-58915884
9. 510(K) SUMARY
510(K) SUMMARY
[as required by 807.92(c)]
| Submitter of 510(k): | Shanghai Pudong Jinhuan Medical Products Co., Ltd.
25 Lianzhen Road, Pudong New Area,
Shanghai 201204, P.R.CHINA.
TEL: 021-50910082 FAX: 021-58915884
E-mail: Jinhuan@sh-Jinhuan.com |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Chen Xiuqin |
| Date of Summary: | Oct 15, 2007 |
| Trade/Proprietary Name: | Shanghai Pudong Jinhuan Medical Products Co., Ltd. |
| Product Code: | GAM |
| | K984374 Samyang Corporation |
| Predicate Device: | K951352 DAVIS & GECK, INC. |
Intended Use:
Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) is indicated for use in general soft tissue approximation including ophthalmic surgery. Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) is not indicated for cardiovascular and neurological tissue approximation.
Device Description:
Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) is a synthetic absorbable suture based on Polyglycolic acid.
Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) coated with polycaprolactone and calcium stearate, has been found to be inert, non-antigenic and nonpyrogenic. Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) are
IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII Shanghai Pudong Jinhuan Medical Products Co., Ltd.
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Image /page/1/Picture/1 description: The image shows a logo for Jinhuan Medical Products. The logo consists of two parts: a circular symbol on the left and the company name on the right. The circular symbol contains two needles pointing downwards, surrounded by a circle with Chinese characters on either side. To the right of the symbol, the words "JINHUAN" are printed in bold, with the words "Medical Products" printed in a smaller font below.
Shanghai Pudong Jinhuan Medical Products Co., Ltd 25 Lianzhen Road, Pudong New Area, Shanghai 201204, P.R.CHINA. TEL: 021-50910082 FAX: 021-58915884 :
available dyed (violet) and undyed. Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) complies with the requirements of USP and EP.
!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! Shanghai Pudong Jinhuan Medical Products Co., Ltd.
.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three overlapping wings, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shanghai Pudong Jinhuan Medical Products Co., Ltd. % PATS Corporation Mr. Brandon Choi General Manager 49 Candlewood Way Buena Park, California 90621
Re: K080412
Trade/Device Name: Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) Regulation Number: 21 CFR 878.4493 Device Name: Absorbable poly(glycolide/L- lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: August 21, 2008 Received: August 26, 2008
SEP - 4 2008
Dear Mr. Choi:
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.
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
3
Page 2 -- Mr. Brandon Choi
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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 surveillance, 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-fre ≥ 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 N. Mikkelsen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED)
Indications for Use: Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) is indicated for use in general soft tissue approximation including ophthalmic surgery. Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) is not indicated for cardiovascular and neurological tissue approximation.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
。 上
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | LC080412 |
|---|---|
| --------------- | ---------- |
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