(176 days)
The Stryker BioZip Suture Anchor is a soft tissue anchor that will be used to secure soft tissue to bone during reconstructive surgery. The anchor is intended for use in such procedures as:
Shoulder: Rotator Cuff Repair Bankart Repair SLAP Lesion Repair Acromio-Clavicular Separation Repair Capsular Shift/Capsulolabral Reconstruction Biceps Tenodesis Deltoid Repair.
Knee: Extra Capsular Repairs Medial Collateral Ligament Lateral Collateral Ligament Posterior Oblique Ligament Illiotibial Band Tenodesis Patellar Tendon Repair. '
Elbow, Wrist, Hand: Scapholunate Ligament Reconstruction Ulnar Collateral Ligament Reconstruction Radial Collateral Ligament Reconstruction Biceps Tendon Reattachment.
Foot and Ankle: Medial Instability Repair/Reconstruction Lateral Instability Repair/Reconstruction Achilles Tendon Repair/Reconstruction Midfoot Reconstruction Hallux Valgus Reconstruction.
Pelvis: Bladder Neck Suspension Procedures.
The Stryker BioZip Suture Anchor is intended for single-use only.
The Stryker BioZip Suture Anchor consists of a Poly L-lactic acid (PLLA) screw-in type suture anchor pre-threaded with two non-absorbable USP braided polyester sutures (one white and one green, needles attached) preloaded on a disposable inserter. The anchor is a bio-absorbable screw with eyelets to receive the sutures and a hex shaped cannulation down its center to accept the inserter's hex shaped tip mates with the anchors hex shaped cannulated core. By rotating the inserter the anchor is screwed into the bone. Once in place the ends of the suture are used to secure soft tissue to the bone.
The Stryker BioZip Suture Anchor will be provided sterile for single-use (ASTM 4169). The device will be sterilized by Ethylene Oxide (EN550) including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10th. The device is biocompatible per ISO-10993 and G95-1.
The provided text describes the Stryker BioZip Suture Anchor, a medical device for securing soft tissue to bone. However, it does not contain details about acceptance criteria, device performance metrics, or a study report that would typically include such information for a new device's clearance.
Instead, this document is a 510(k) Summary of Safety and Effectiveness for the Stryker BioZip Suture Anchor, submitted to the FDA. The primary purpose of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This is achieved by comparing the new device's technological characteristics and intended use to those of the predicate.
Here's what can be extracted from the document, though it won't directly answer all your questions about acceptance criteria and a detailed performance study:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria (Implied by Substantial Equivalence): The implicit acceptance criterion for a 510(k) submission is "substantially equivalent performance" to the predicate device in terms of intended use, safety, and efficacy. Specific quantitative acceptance criteria (e.g., maximum pull-out strength, degradation rate) are not explicitly stated in this summary for the product's performance but would have been part of the testing supporting the substantial equivalence claim.
- Reported Device Performance:
- Intended Use: Securing soft tissue to bone using suture in reconstructive surgery.
- Material: Poly L-lactic acid (PLLA) for the anchor, with non-absorbable USP braided polyester sutures.
- Sterility: Provided sterile for single-use (ASTM 4169), sterilized by Ethylene Oxide (EN550) to a sterility assurance level (SAL) of 10^-6.
- Biocompatibility: Biocompatible per ISO-10993 and G95-1.
- Comparison to Predicate: "The subject device was shown to have substantially equivalent performance when compared to the predicate device." (Predicate: Arthrex 5.0 mm Bio-Corkscrew Suture Anchor, K990987).
2. Sample Size for the Test Set and Data Provenance:
- Not specified. The document does not provide details on specific sample sizes for performance testing. Data provenance (country of origin, retrospective/prospective) is also not mentioned. This type of detail would typically be found in the full test report, not the 510(k) summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable/Not specified. This type of information is usually relevant for studies involving human interpretation (e.g., imaging studies). For a mechanical device like a suture anchor, "ground truth" would be established through engineering and materials testing, not expert consensus on interpretations. The document does not mention any expert panels for ground truth determination.
4. Adjudication Method for the Test Set:
- Not applicable/Not specified. As "ground truth" is not established by human review for this type of device, an adjudication method like 2+1 or 3+1 is not relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. An MRMC study is typically for evaluating diagnostic or imaging systems where human readers interpret data. This is a surgical implant, so an MRMC study is not relevant.
6. If a Standalone Performance Study (Algorithm Only) Was Done:
- Not applicable. This is a physical medical device, not an algorithm. Performance studies would involve mechanical and biological testing. The summary states "The subject device was shown to have substantially equivalent performance when compared to the predicate device," which implies standalone performance testing was conducted and compared, but specifics are absent in this summary.
7. The Type of Ground Truth Used:
- For this device, "ground truth" would be established through:
- Engineering and Mechanical Testing: Such as pull-out strength, torque performance, fatigue testing, degradation characteristics, etc.
- Biocompatibility Testing: In vitro and in vivo tests to ensure the material is safe for implantation.
- Sterility Testing: Validation of the sterilization process.
- However, the summary document does not explicitly detail the specific ground truth metrics or methodologies used, only stating that it proved substantial equivalence to the predicate.
8. The Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, no training set for an algorithm.
In summary: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed report of a performance study with explicit acceptance criteria and results. While it confirms that studies were conducted to prove biocompatibility, sterility, and performance to establish substantial equivalence, it does not include the detailed quantitative data you've requested.
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MAR 2 0 2003
SUMMARY OF SAFETY AND EFFECTIVENESS
Device Name
Classification Name: Classification: Common and Usual Name: Proprietary Name:
Fastener, Fixation, Biodegradable, Soft Tissue 21 CFR §888.3040, Class II Bioabsorbable Suture Anchor Stryker BioZip Suture Anchor
Predicate Device
Arthrex 5.0 mm Bio-Corkscrew Suture Anchor (#K990987) currently marketed by Arthrex, Inc. (Naples, FL).
Summary
This summary of 510(k) safety and effectiveness is being submitted in accordance with requirements of SMDA 1990.
The Stryker BioZip Suture Anchor is intended for use in reconstructive surgery to secure soft tissue to bone using suture. The suture anchor fixation technique is a common method in orthopedic surgery, and has been well published in professional journals such as Arthroscopy: The Journal of Arthroscopic and Related Surgery.
The Stryker BioZip Suture Anchor consists of a Poly L-lactic acid (PLLA) screw-in type suture anchor pre-threaded with two non-absorbable USP braided polyester sutures (one white and one green, needles attached) preloaded on a disposable inserter. The anchor is a bio-absorbable screw with eyelets to receive the sutures and a hex shaped cannulation down its center to accept the inserter's hex shaped tip mates with the anchors hex shaped cannulated core. By rotating the inserter the anchor is screwed into the bone. Once in place the ends of the suture are used to secure soft tissue to the bone.
The Stryker BioZip Suture Anchor will be provided sterile for single-use (ASTM 4169). The device will be sterilized by Ethylene Oxide (EN550) including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10th. The device is biocompatible per ISO-10993 and G95-1. The Stryker BioZip Suture Anchor is equivalent in intended use, safety, and efficacy to the predicate device. The subject device was shown to have substantially equivalent performance when compared to the predicate device.
The Stryker BioZip Suture Anchor is considered substantially equivalent to the Arthrex Bio-Corkscrew Suture Anchor.
Contact:
Date: 01/15/03
Alisa Miller Senior Quality Engineer Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 (408) 754-2259
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2003
Ms. Alisa Miller Senior Quality Engineer Stryker Endoscopy 5900 Optical Court San Jose, California 95138
Re: K023192
Trade/Device Name: Stryker Biozip Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: January 15, 2003 Received: January 21, 2003
Dear Ms. Miller:
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 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Alisa Miller
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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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,
s Mark N Milkers
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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January 15, 2003
510(k) Number: K023192
INDICATION FOR USE:
The Stryker BioZip Suture Anchor is a soft tissue anchor that will be used to secure soft tissue to
bone during reconstructive surgery. The anchor is intended for use in such procedures as:
Shoulder: Rotator Cuff Repair Bankart Repair SLAP Lesion Repair Acromio-Clavicular Separation Repair Capsular Shift/Capsulolabral Reconstruction Biceps Tenodesis Deltoid Repair.
Knee: Extra Capsular Repairs Medial Collateral Ligament Lateral Collateral Ligament Posterior Oblique Ligament Illiotibial Band Tenodesis Patellar Tendon Repair. '
Elbow, Wrist, Hand: Scapholunate Ligament Reconstruction Ulnar Collateral Ligament Reconstruction Radial Collateral Ligament Reconstruction Biceps Tendon Reattachment.
Foot and Ankle: Medial Instability Repair/Reconstruction Lateral Instability Repair/Reconstruction Achilles Tendon Repair/Reconstruction Midfoot Reconstruction Hallux Valgus Reconstruction.
Pelvis: Bladder Neck Suspension Procedures.
The Stryker BioZip Suture Anchor is intended for single-use only.
(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
| Labels | Values |
|---|---|
| 510(k) Number | K023192 |
Prescription Use Yes OR Over-the-Counter Use No
(Per 21 CFR 801.109)
2
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.