(36 days)
K946173, NDA 16-374
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a surgical suture, with no mention of AI or ML technologies.
No.
This device is a surgical suture used for tissue approximation and ligation, which is a supportive role in a medical procedure, not a device that directly treats a condition or disease.
No
Explanation: The device is described as a surgical suture used for soft tissue approximation and ligation. It is a tool used during medical procedures and does not perform any diagnostic function.
No
The device description clearly states it is a surgical suture composed of polypropylene, which is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- PROLENE™ Suture Function: The description clearly states that PROLENE™ suture is a surgical suture used for "general soft tissue approximation and/or ligation." This means it is used within the body during surgery to hold tissues together or tie off blood vessels.
- No Specimen Examination: There is no mention of collecting, preparing, or examining any specimens from the body. The device is directly applied to the patient's tissues.
The information provided describes a surgical implant, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
PROLENE™ suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Product codes
GAW
Device Description
PROLENETM Polypropylene Suture (clear or pigmented) is a nonabsorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The pigmented suture is pigmented blue (with phthalocyanine blue, Color Index Number 74160) to enhance visibility. PROLENE™ suture, also available as PROLENE™ HEMO-SEAL™ needle suture, is a needle suture combination in which the diameter of the suture swage area has been reduced to facilitate attachment of finer wire diameter needles. The diameter of the suture strand and the needle wire have been more closely aligned to reduce the degree of needle hole bleeding.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general 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
Design Verification Testing (U.S.P. - Sutures - Needle Performance Data Attachment; U.S.P. - Tensile Strength; U.S.P. - Sutures -Diameter) was conducted to demonstrate the performance of the modified PROLENE™ HEMOSEAL™ Polypropylene Nonabsorbable Suture.
Key Metrics
Not Found
Predicate Device(s)
K946173, NDA 16-374
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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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K133356 Page 1/3
510(k) SUMMARY
| Sponsor: | ETHICON, Inc. P.O. Box 151 Route 22 West Somerville, New Jersey 08876 |
|---|---|
| Contact: | Elliott Jang, RAC ETHICON, Inc. P.O. Box 151 Route 22 West Somerville, New Jersey 08876 Phone: 908-541-3817 Fax: 908-218-2595 Email: ejang1@its.jnj.com |
| DEC 0 6 2013 | |
| Date of Submission: | October 28, 2013 |
| Proprietary Name: | PROLENET™ Polypropylene Nonabsorbable Suture |
| Common Name: | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Regulation: | 21 CFR 878.5010 |
| Regulatory Class: | II |
| Product Code: | GAW |
| Predicate Devices: | Labeling Changes for Generic Suture Types, by Ethicon Inc., K946173, cleared January 9, 1995 |
| PROLENE Polypropylene Suture (Nonabsorbable Surgical Suture, U.S.P., Type B), by Ethicon Inc., NDA 16-374 approved April 16, 1969 followed by multiple supplements (converted from drug to PMA device in 1983 and then reclassified to class II device in 1990) | |
| Device Description: | PROLENETM Polypropylene Suture (clear or pigmented) is a nonabsorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The pigmented suture is pigmented blue (with phthalocyanine blue, Color Index Number 74160) to enhance visibility. |
.
ETHICON, Inc.
ﺎ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
1
PROLENE™ Polypropylene Nonabsorbable Suture Special 510(k) Pre-Market Notification
PROLENE™ suture, also available as PROLENE™ HEMO-SEAL™ needle suture, is a needle suture combination in which the diameter of the suture swage area has been reduced to facilitate attachment of finer wire diameter needles. The diameter of the suture strand and the needle wire have been more closely aligned to reduce the degree of needle hole bleeding.
The subject device is identical to the predicate device in all aspects, including design, materials, sterilization, and packaging. The only difference between the proposed and the predicate devices is that the proposed device now meets U.S.P. for needle attachment force and that is now reflected in the labeling.
PROLENE™ suture is indicated for use in general soft tissue Indications for Use approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Summary of Technological Characteristics of Modified Device to Predicate
The principle of operation and fundamental scientific technology of the modified device are equivalent to the predicate device. The performance modification was accomplished via adjustments to the swaging process settings. A comparison between the proposed and the predicate device is given in Table 1 below.
| Proposed Device | Predicate Device | |
|---|---|---|
| 510(k) Number | TBD | K946173 |
| Product Code | Same | GAW |
| Regulation | Same | 21 CFR 878.5010 |
| Absorbable | Same | No |
| Intended Use | Same | PROLENE suture is indicated |
| for use in general soft tissue | ||
| approximation and/or ligation, | ||
| including use in cardiovascular, | ||
| ophthalmic and neurological | ||
| procedures. | ||
| How Supplied | Same | The devices are available in |
| one, two, or three dozen boxes. | ||
| Color | Same | Clear or Pigmented suture |
| strands (pigmented blue with | ||
| phthalocyanine blue, Color | ||
| Index Number 74160) | ||
| Material | ||
| Composition | Same | Composed of an isotactic |
| crystalline stereoisomer of | ||
| polypropylene, a synthetic | ||
| linear polyolefin. | ||
| Sterilization | Same | Sterilized by Ethylene Oxide |
| Packaging | Same | Plastic tray or paper folder |
| placed within sealed Tyvek - |
Table 1: Device Comparison Table
ETHICON, Inc.
2
PROLENE™ Polypropylene Nonabsorbable Suture Special 510(k) Pre-Market Notification
| Image: [Blurred image] | copolymer overwrap.
Individual overwrap pouch
packages placed within
paperboard carton. | |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| U.S.P.
requirements
Image: [Blurred image] | Meets U.S.P.
Monograph – except
for Diameter for 7-0
PROLENE | Meets U.S.P. Monograph –
except for Diameter for 7-0
PROLENE, and except for
Needle Attachment for HEMO-
SEAL. |
Design Verification Testing (U.S.P. - Sutures - Needle Performance Data Attachment; U.S.P. - Tensile Strength; U.S.P. - Sutures -Diameter) was conducted to demonstrate the performance of the modified PROLENE™ HEMOSEAL™ Polypropylene Nonabsorbable Suture.
Based on the similarities to the predicate device identified in this Conclusions submission as well as the outcome of design verification, and that the devices have the same intended use, the same fundamental technology, and the same principle of operation, we conclude that the modified device is substantially equivalent to the predicate devices.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Frampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 6, 2013
Ethicon, Incorporated Mr. Elliott Jang, RAC Manager, Regulatory Affairs Route 22 West, P.O. Box 151 Somerville. New Jersey 08876
Re: K133356
Trade/Device Name: PROLENE™ POLYPROPYLENE NONABSORBABLE SUTURE Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: Class II Product Code: GAW Dated: November 18, 2013 Received: November 19. 2013
Dear Mr. Jang:
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). and obsintherefore, market the device, subject to the general controls provisions of the Act. The . Fou may , increaser , 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 cither 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 or any rederal station and sequirements, 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
4
· Page 2 - Mr. Elliott Jang, RAC
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510{k} Number (if known) K133356
Device Name
PROLENE™ POLYPROPYLENE NONABSORBABLE SUTURE
Indications for Use (Describe)
PROLENE™ suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)