(28 days)
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.
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.
The provided text is a 510(k) summary for a medical device (Passing Needle with various sutures) that seeks to demonstrate substantial equivalence to existing predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through testing.
Instead, the document primarily focuses on:
- Device Classification and Description: Details about the sutures used and the intended use of the passing needle assemblies.
- Substantial Equivalence: Listing predicate devices (previously cleared sutures) to which the current device is deemed substantially equivalent.
- Indications for Use: What orthopaedic procedures the device is intended for.
- Safety Reference: Stating that safety data for the sutures can be referenced in the clearance documents of the predicate devices.
Therefore, I cannot provide the requested information, which typically pertains to performance studies with specific metrics, acceptance criteria, sample sizes, and ground truth establishment. This type of information is usually found in detailed performance study reports, not in a 510(k) summary that relies on substantial equivalence.
To answer your request, if this were a document that did contain such a study (e.g., a clinical trial report or a comprehensive bench testing report), the table and other details would look something like this (hypothetical example, as the provided text doesn't support it):
(Hypothetical Example Based on a Fictional Performance Study)
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tensile Strength (Suture A) | Mean tensile strength ≥ X Newtons | Mean tensile strength = X+Y Newtons (Pass) |
| Knot Security (Suture B) | No slippage or breakage at Z Newtons of force | No slippage or breakage observed up to Z+W Newtons (Pass) |
| Needle Bend/Breakage (Needle Type 1) | < 1% incidence of bending/breakage during simulated use | 0.5% incidence of bending (no breakage) over N cycles (Pass) |
| Passage Force (Needle Type 2) | Mean passage force ≤ P Newtons in ex-vivo tissue | Mean passage force = P-Q Newtons (Pass) |
| Biocompatibility | Meets ISO 10993 standards (e.g., cytotoxicity, sensitization) | All tests within acceptable limits (Pass) |
| Sterility Assurance Level (SAL) | SAL of 10^-6 agreed post-sterilization | Achieved SAL of 10^-6 (Pass) |
2. Sample sized used for the test set and the data provenance
- Tensile Strength (Suture A): Test Set N=50 sutures. Data provenance: Manufactured samples, tested in an independent lab in the USA (prospective bench testing).
- Knot Security (Suture B): Test Set N=60 sutures (10 knots per condition). Data provenance: Manufactured samples, tested in a material science lab in Germany (prospective bench testing).
- Needle Bend/Breakage (Needle Type 1): Test Set N=100 needles. Data provenance: Manufactured samples, tested in a biomechanics lab in the USA using a custom-built cyclic loading apparatus (prospective bench testing).
- Passage Force (Needle Type 2): Test Set N=40 needles, 10 passes each in 5 different types of ex-vivo animal tissue samples. Data provenance: Manufactured samples, tested in a university biomechanics department in Canada using porcine and bovine tissue (prospective ex-vivo testing).
- Biocompatibility: Test materials (extracts, direct contact with cell cultures) from N=3 production lots. Data provenance: Independent contract lab, USA (prospective in-vitro/in-vivo animal testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- For bench and ex-vivo tests, "ground truth" is typically defined by the physical measurement or observation itself, not expert consensus. Calibrated instruments and standardized protocols establish the truth.
- However, if there was a subjective component (e.g., visual assessment of tissue damage from needle pass), it might involve:
- Needle Passage Tissue Trauma Assessment: 3 board-certified orthopedic surgeons (average 15 years experience) evaluated tissue samples for trauma severity using a blinded scoring system.
4. Adjudication method for the test set
- For objective bench data (tensile strength, breakage force, passage force): No adjudication as measurements are quantitative and performed by calibrated equipment according to standard protocols. Any outliers would be investigated for experimental error or manufacturing defects.
- For subjective assessments (e.g., tissue trauma): If used, a 3-way consensus method or 2+1 adjudication (if 2 experts agreed, that was the ground truth; if not, a third expert resolved the discrepancy) would be applied.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No, MRMC studies are typically for diagnostic imaging devices where human readers interpret images with and without AI assistance. This device is a surgical tool (needle and suture assembly), so such a study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this is a physical surgical device, not a software algorithm.
7. The type of ground truth used
- Objective Measurement: Quantitative physical properties (tensile strength, force measurement, cycle counts) determined by calibrated test equipment.
- Visual Inspection/Physical Observation: For breakage events or gross damage, directly observed under magnification.
- Standardized Laboratory Assays: For biocompatibility (e.g., cell viability assays, irritation tests).
8. The sample size for the training set
- Not applicable in this context. Training sets are relevant for AI/ML algorithms. For physical devices, design parameters are developed through engineering and material science principles, often with iterative prototyping and testing, but not a "training set" in the AI sense.
9. How the ground truth for the training set was established
- Not applicable.
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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 Miteka Johnson & Johnson company249 Vanderbilt AvenueNorwood, MA 02062 |
|---|---|
| Contact Person | Ruth C. ForstadtProject Management Lead, Regulatory AffairsDePuy Miteka Johnson & Johnson company249 Vanderbilt AvenueNorwood, MA 02062Telephone: 781-251-3188Facsimile: 781-278-9578e-mail: rforstad@dpyus.jnj.com |
| Name of Medical Device | Classification Name: ETHIBONDNon-absorbable poly(ethylene terephthalate)suture under 21 CFR 878.5000.PANACRYLAbsorbable surgical suture, polydiaxanoneunder 21 CFR 878.4493.ORTHOCORDPDS Suture carries an FDA product codeNEW, and is classified as absorbable surgicalsuture, polydiaxanone under 21 CFR878.4840.Polyethylene sutures carries an FDA productcode GAT, and is classified under 21 CFR878.5000.Common/Usual Name: SutureProprietary Name: Passing Needle with ETHIBOND,PANACRYL or ORTHOCORD suture; andPassing Needle with ETHIBOND Loop |
Premarket Notification: Traditional Passing Needles with ETHIBOND, PANACRYL or ORTHOCORD suture Passing Needle with ETHIBOND Loop
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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 orORTHOCORD suture is a suture and needle assembly to be used invivo for suture passage through soft tissue during the surgicalprocedure. It is packaged with two colored clips and is designed to beused with the Mitek Suture Passer. The Passing Needle withPANACRYL, ETHIBOND or ORTHOCORD suture may also be usedwith other Mitek anchor products.Mitek Passing Needle with ETHIBOND Loop is a utility suture andneedle assembly that is used in vivo for suture passage of operativesuture through soft tissue during the surgical procedure. It ispackaged with a colored clip and is designed to be used with the MitekSuture Passer. |
| Indications for Use | Passing Needle with PANACRYL, ETHIBOND, orORTHOCORD suture is indicated for use in general soft tissueapproximation and/or ligation in orthopedic procedures. SpecificallyArthroscopic Bankart and Rotator Cuff Procedures encompassingtendon and ligament reconstruction.Mitek Passing Needle with ETHIBOND Loop is indicated for use ingeneral soft tissue approximation and/or ligation in orthopedicprocedures. Specifically Arthroscopic Bankart and Rotator CuffProcedures 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. |
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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
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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
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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
§ 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.