(89 days)
NDA 17-804, NDA 16-374
Not Found
No
The summary describes a mechanical fastener system and its performance testing, with no mention of AI, ML, image processing, or data-driven algorithms.
Yes.
The device is used for the attachment of surgical mesh and suture to ligaments of the pelvic floor, which implies a therapeutic intervention (e.g., repairing or supporting tissues).
No
The device is described as a fastener system used for the attachment of surgical mesh and suture to ligaments of the pelvic floor, indicating a therapeutic or surgical function rather than a diagnostic one.
No
The device description explicitly states it consists of an "implantable nonabsorbable PROLENE polypropylene Fastener," which is a physical hardware component. The performance studies also focus on the mechanical properties and holding strength of this physical fastener.
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 the "attachment of knitted, nonwoven surgical mesh and suture to ligaments of the pelvic floor." This is a surgical procedure performed in vivo (within the living body).
- Device Description: The device is described as an "implantable nonabsorbable PROLENE polypropylene Fastener." This is a physical implant used during surgery.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's condition
- Using reagents or assays
IVDs are used to examine specimens in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. This device is a surgical tool and implant used in vivo.
N/A
Intended Use / Indications for Use
The GYNECARE PROLENE Fastener System is indicated for the attachment of knitted, non-woven surgical mesh and suture to ligaments of the pelvic floor.
Product codes
PBQ
Device Description
The GYNECARE PROLENE Fastener consists of the implantable nonabsorbable PROLENE polypropylene Fastener.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor
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
Performance testing:
- Design Verification of the GYNECARE PROLENE Fastener with a Distributed Load .
- Design Verification of the GYNECARE PROLENE Fastener with a Point Load .
- Design Verification for the Tensile Strength of the GYNECARE PROLENE Fastener with . GYNECARE GYNEMESH* PS
- . Design Verification for the In-Vivo Comparison Between the Tissue Pullout Force of Suture and the GYNECARE PROLENE Fastener
- Holding Strength of the GYNECARE PROLENE Fastener in the Sacrospinous Ligament .
Key Metrics
Not Found
Predicate Device(s)
ETHIBOND EXCEL suture - NDA 17-804, ETHICON PROLENE suture - NDA 16-374
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
HICON, inc. GYNECARE PROLENE Fastener System
DEC 2 2 2004
K042603
510(k) Premarket Notification
December 20, 2004
510(k) Summary
| Trade Name: | GYNECARE PROLENE Fastener System |
|---|---|
| Sponsor: | ETHICON, inc. |
| Route 22 West | |
| Somerville, NJ 08876 | |
| Contact: | Sean O'Bryan, Senior Project Manager, Regulatory Affairs; Tel: 908-218-2456 |
| Device Generic Name: | Implantable staple, nonabsorbable (21 CFR 878.4750) |
| Classification: | According to Section 513 of the Federal Food, Drug, and |
| Cosmetic Act, the device classification is Class II. | |
| Product Code: | PBQ |
| Predicate Device(s): | ETHIBOND EXCEL suture - NDA 17-804 |
| ETHICON PROLENE suture - NDA 16-374 | |
| Product Description: | The GYNECARE PROLENE Fastener consists of the implantable |
| nonabsorbable PROLENE polypropylene Fastener. |
Indications for Use:
The GYNECARE PROLENE Fastener System is indicated for the attachment of knitted, non-woven surgical mesh and suture to ligaments of the pelvic floor.
Safety and Performance:
The following safety and performance data has been provided to support substantial equivalence of the GYNECARE PROLENE Fastener System:
Performance testing:
- Design Verification of the GYNECARE PROLENE Fastener with a Distributed Load .
- Design Verification of the GYNECARE PROLENE Fastener with a Point Load .
- Design Verification for the Tensile Strength of the GYNECARE PROLENE Fastener with . GYNECARE GYNEMESH* PS
- . Design Verification for the In-Vivo Comparison Between the Tissue Pullout Force of Suture and the GYNECARE PROLENE Fastener
- Holding Strength of the GYNECARE PROLENE Fastener in the Sacrospinous Ligament .
Conclusion:
Based on 1) safety and performance data, and 2) similarities in design, operating principles, biocompatibility and sterilization method, the GYNECARE Fastener System has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird in flight, with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 1. 2013
ETHICON, Inc. % Mr. Sean O'Bryan Senior Project Manager, Regulatory Affairs Route 22 West SOMERVILLE NJ 08876
Re: K042603
Trade/Device Name: Gynecare Prolene Fastener System Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: PBQ Dated (Date on orig SE ltr): November 18, 2004 Received (Date on orig SE ltr): November 22, 2004
Dear Mr. O'Bryan:
This letter corrects our substantially equivalent letter of December 22, 2004.
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 (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 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
2
Page 2 - Mr. Sean O'Bryan
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Safetv/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 Small Manufacturers, International and Consumer Assistance 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 yours,
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K042603
Device Name: GYNECARE PROLENE Fastener System
Indications For Use:
The GYNECARE PROLENE Fastener System is indicated for the attachment of knitted, nonwoven surgical mesh and suture to ligaments of the pelvic floor.
Prescription Use X (Part 21 CFR 801 Subpart D) 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)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K042603