(28 days)
Not Found
No
The device description and intended use focus on a physical suture and needle assembly for soft tissue approximation, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
No
The device is a needle and suture assembly used for soft tissue approximation and ligation during orthopedic surgical procedures, which are restorative rather than therapeutic.
No
The device description and intended use indicate it is an assembly for suture passage and soft tissue approximation/ligation during surgical procedures, not for diagnostic purposes.
No
The device description clearly describes a physical suture and needle assembly intended for in vivo use during surgical procedures. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that this device is a "suture and needle assembly to be used in vivo for suture passage through soft tissue during the surgical procedure." This means it is used inside the body during surgery.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information about a patient's condition. Its purpose is purely for surgical repair and reconstruction.
Therefore, this device falls under the category of a surgical instrument or implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Passing Needle with PANACRYL, ETHIBOND, or ORTHOCORD suture is indicated for use in general soft tissue approximation and/or ligation in orthopedic procedures. Specifically Arthroscopic Bankart and Rotator Cuff Procedures encompassing tendon and ligament reconstruction.
Mitek Passing Needle with ETHIBOND Loop is indicated for use in general soft tissue approximation and/or ligation in orthopedic procedures. Specifically Arthroscopic Bankart and Rotator Cuff Procedures encompassing tendon and ligament reconstruction.
Product codes
GAM, NEW, GAT
Device Description
Mitek Passing Needle with ETHIBOND, PANACRYL or ORTHOCORD suture is a suture and needle assembly to be used in vivo for suture passage through soft tissue during the surgical procedure. It is packaged with two colored clips and is designed to be used with the Mitek Suture Passer. The Passing Needle with PANACRYL, ETHIBOND or ORTHOCORD suture may also be used with other Mitek anchor products.
Mitek Passing Needle with ETHIBOND Loop is a utility suture and needle assembly that is used in vivo for suture passage of operative suture through soft tissue during the surgical procedure. It is packaged with a colored clip and is designed to be used with the Mitek Suture Passer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, tendon and ligament
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K964345, NDA 17-804, NDA 17-809, K040004
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
AUG - 3 2004
K041806 Page 1/2
SECTION 2 – 510(k) SUMMARY
Passing Needle with ETHIBOND, PANACRYL or ORTHOCORD suture; and Passing Needle with ETHIBOND Loop
| Submitter's Name and Address: | DePuy Mitek
a Johnson & Johnson company
249 Vanderbilt Avenue
Norwood, MA 02062 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ruth C. Forstadt
Project Management Lead, Regulatory Affairs
DePuy Mitek
a Johnson & Johnson company
249 Vanderbilt Avenue
Norwood, MA 02062
Telephone: 781-251-3188
Facsimile: 781-278-9578
e-mail: rforstad@dpyus.jnj.com |
| Name of Medical Device | Classification Name: ETHIBOND
Non-absorbable poly(ethylene terephthalate)
suture under 21 CFR 878.5000.
PANACRYL
Absorbable surgical suture, polydiaxanone
under 21 CFR 878.4493.
ORTHOCORD
PDS Suture carries an FDA product code
NEW, and is classified as absorbable surgical
suture, polydiaxanone under 21 CFR
878.4840.
Polyethylene sutures carries an FDA product
code GAT, and is classified under 21 CFR
878.5000.
Common/Usual Name: Suture
Proprietary Name: Passing Needle with ETHIBOND,
PANACRYL or ORTHOCORD suture; and
Passing Needle with ETHIBOND Loop |
Premarket Notification: Traditional Passing Needles with ETHIBOND, PANACRYL or ORTHOCORD suture Passing Needle with ETHIBOND Loop
1
K041806 page 2/2
| Substantial Equivalence | PANACRYL sutures have been cleared by FDA - K964345;
ETHIBOND sutures have been approved by FDA - NDA 17-804 &
17-809;
ORTHOCORD sutures have been cleared by FDA- K040004 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification | Sutures are Class II devices. |
| Device Description | Mitek Passing Needle with ETHIBOND, PANACRYL or
ORTHOCORD suture is a suture and needle assembly to be used in
vivo for suture passage through soft tissue during the surgical
procedure. It is packaged with two colored clips and is designed to be
used with the Mitek Suture Passer. The Passing Needle with
PANACRYL, ETHIBOND or ORTHOCORD suture may also be used
with other Mitek anchor products.
Mitek Passing Needle with ETHIBOND Loop is a utility suture and
needle assembly that is used in vivo for suture passage of operative
suture through soft tissue during the surgical procedure. It is
packaged with a colored clip and is designed to be used with the Mitek
Suture Passer. |
| Indications for Use | Passing Needle with PANACRYL, ETHIBOND, or
ORTHOCORD suture is indicated for use in general soft tissue
approximation and/or ligation in orthopedic procedures. Specifically
Arthroscopic Bankart and Rotator Cuff Procedures encompassing
tendon and ligament reconstruction.
Mitek Passing Needle with ETHIBOND Loop is indicated for use in
general soft tissue approximation and/or ligation in orthopedic
procedures. Specifically Arthroscopic Bankart and Rotator Cuff
Procedures encompassing tendon and ligament reconstruction. |
| Safety | These sutures have been cleared through K964345 (PANACRYL),
NDA 17-804 & 17-809 (ETHIBOND) and K040004
(ORTHOCORD). Safety data may be referenced in these documents. |
Image /page/1/Picture/3 description: The image is completely black. There are no discernible shapes, patterns, or objects within the frame. The entire image is filled with a uniform black color, creating a solid, dark void.
2
Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text around the perimeter appears to be the name of an organization or agency, possibly related to health or human services. The symbol in the center consists of three stylized lines or curves, resembling a bird or a flowing design. The logo has a simple, monochrome design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
UG = 3 2004
Ms. Ruth C. Forstadt Project Management Lead, Regulatory Affairs DePuy Mitek A Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, Massachusetts 02062
Re: K041806
Trade/Device Name: Passing Needle with Ethibond, Panacryl or Orthocord suture; and Passing Needle with Ethibond Loop Regulation Number: 21 CFR 878.4493, 21 CFR 878.4840, 21 CFR 878.5000 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture; Absorbable polydioxanone surgical suture; Nonabsorbable poly(ethylene terephthalate) surgical suture. Regulatory Class: II
Product Code: GAM, NEW, GAT Dated: June 30, 2004 Received: July 6, 2004
Dear Ms. Forstadt:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrease) of the enactment date of the Medical Device Amendments, or to eoniner of the been reclassified in accordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Cosmetre Prov (100) and the device, subject to the general controls provisions of the Act. The I va may, increrere, mains 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 n your device to such additional controls. Existing major regulations affecting your device can may be subject to back as a submitted and 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 r rease be arrison a determination that your device complies with other requirements of the Act that I Dr Haal statutes and regulations administered by other Federal agencies. You must
3
Page 2 - Ms. Ruth C. Forstadt
comply with all the Act's requirements, including, but not limited to: registration and listing (21 comply with an the Act 3 requirements, 01); good manufacturing practice requirements as set CFR Fart 807), adomig (21 CFR Part 820); and if applicable, the electronic form in the quality systems (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) This letter whit anow you to begin mailing of substantial equivalence of your device to a legally prematication. The PDF Intellig sification 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 If you ucsire specific acries ion 100 - 301) 594-4659. Also, please note the regulation entitled, Comaci the Office of Council cation" (21CFR Part 807.97). You may obtain Missuranting of telefonoe to premation on your the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. 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): KOY (806
Passing Needle with ETHIBOND, PANACRYL or ORTHOCORD suture; Device Name:__________________________________________________________________________________________________________________________________________________________________ and Passing Needle with ETHIBOND Loop
Indications For Use:
Passing Needle with ETHIBOND, PANACRYL or ORTHCORD subure is indicated for use in Passing Needle With ETHIBOND, I ANTICA I D Chrosedic procedures. Specifically Arthroscopic
general soft tissue approximation and/or ligation in orthopedia.organstration general son thsue approximation and of inguited in consisted on and ligament reconstruction.
Bankart and Rotator Cuff Procedures encompassing tendon and ligament reconstructi
Passing Needle with ETHIBOND Loop is indicated for use in general soft issue approximation and/or Passing Needle will ETHIDOND Evop is marcated for as a good and and Rotator Cuff Procedures encompassing tendon and ligament reconstruction.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use ---------(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | Miriam C. Provost |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | K041806 |
| Page 1 of |
Premarket Notification: Traditional
Passing Needles with ETHIBOND, PANACRYL or ORTHOCORD suture
Passing Needle with ETHIBOND Loop