(28 days)
The Stryker XCEL Anchor System is intended for use in securing soft tissue to bone in such procedures as:
Shoulder:
Bankart repair
SLAP lesion repair
Rotator cuff repair
Capsular shift repair
Biceps tenodesis
Acromio-clavicular separation
Knee:
Medial collateral ligament repair
Lateral collateral ligament repair
Joint capsule closure to anterior proximal tibia
Posterior oblique ligament or joint capsule to tibia repair
Extra capsular reconstruction/ITB tenodesis
Patellar ligament and tendon avulsion repairs
Elbow:
Biceps tendon reattachment
Foot & Ankle:
Achilles tendon repair/reconstruction
Lateral stabilization
Medial stabilization
The Stryker XCEL Anchor System is intended for single-use only.
The line extension of the Stryker XCEL Anchor System consists of a Poly L-lactic acid (PLLA) anchor pre-threaded with non-absorbable braided polyethylene surgical suture, and pre-assembled on a disposable inserter.
The provided document is a 510(k) summary for the Stryker XCEL Anchor System, a medical device intended for securing soft tissue to bone. It's a "line extension" of an existing device, meaning it's substantially equivalent to a previously cleared product.
Here's the information regarding acceptance criteria and the study, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in terms of performance metrics (e.g., tensile strength, pull-out force with specific thresholds). Instead, the acceptance criterion for this 510(k) "line extension" is primarily substantial equivalence to the predicate device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (K023013) | "The line extension of the Stryker XCEL Anchor System is substantially equivalent in material of construction, overall design, intended use, and safety and efficacy to the predicate device. The subject device was shown to have substantially equivalent performance when compared to the predicate device." |
| Sterility (SAL of 10^-6) | "The line extension of the Stryker XCEL Anchor System will be provided sterile for single-use (ASTM 4169)... validated to a sterility assurance level (SAL) of 10−⁶." |
| Biocompatibility (per ISO-10993-1 and G95-1) | "The device is biocompatible per ISO-10993-1 and G95-1." |
| Ethylene Oxide Residuals (limits per ANSI/AAMI/ISO 11135) | "The device will be sterilized by Ethylene Oxide (ANSI/AAMI/ISO 11135), including limits for Ethylene Oxide residuals..." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on specific sample sizes for a test set or the provenance (country of origin, retrospective/prospective) of data used for any specific performance testing. The focus of this 510(k) summary is on demonstrating substantial equivalence rather than presenting detailed raw study data. It implies that performance testing was conducted, but the specifics are not included in this high-level summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This document does not describe a clinical study with human patients where expert adjudication of outcomes would be required to establish "ground truth." The evaluation here is for a medical device's substantial equivalence to a predicate, not a diagnostic algorithm. Therefore, information about experts for ground truth is not applicable in this context.
4. Adjudication Method for the Test Set
As there's no mention of a clinical study generating a "test set" requiring human interpretation or diagnosis, there's no adjudication method described in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done for this 510(k) application. This type of study is typically for evaluating the impact of an AI-powered diagnostic tool on human reader performance. The Stryker XCEL Anchor System is a physical surgical implant, not a diagnostic AI device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
N/A. This is not an algorithm or AI device, so the concept of standalone performance does not apply.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to established standards and predicate device performance. The type of "ground truth" used for demonstrating substantial equivalence includes:
- Existing Predicate Device Performance: The primary ground truth is the established safety and efficacy profile of the predicate device (Stryker XCEL Anchor System, K023013). The new device is compared against this.
- Industry Standards: Compliance with standards like ASTM 4169 (sterility), ANSI/AAMI/ISO 11135 (EO sterilization and residuals), and ISO-10993-1/G95-1 (biocompatibility) serve as ground truth for specific aspects of the device.
8. The Sample Size for the Training Set
There is no mention of a "training set" as this is not an artificial intelligence or machine learning device. The term "training set" is not applicable.
9. How the Ground Truth for the Training Set was Established
As there is no training set, this question is not applicable.
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JUN 1 4 2004
Endoscopy
SUMMARY OF SAFETY AND EFFECTIVENESS
Device Name
Classification Name:
Common and Usual Name: Proprietary Name:
Fastener, Fixation, Biodegradable, Soft Tissue 21 CFR §888.3040, Class II Bioabsorbable Suture Anchor (MAI) Stryker XCEL Anchor System
Predicate Device
Stryker XCEL Anchor System (#K023013), currently marketed by Stryker Endoscopy (San Jose, CA),
Summary
This summary of Special 510(k) safety and effectiveness is being submitted in accordance with requirements of SMDA 1990.
The line extension of the Stryker XCEL Anchor System is intended for use in providing a means for securing soft tissue to bone using suture. The line extension of the Stryker XCEL Anchor System consists of a Poly L-lactic acid (PLLA) anchor pre-threaded with non-absorbable braided polyethylene surgical suture, and pre-assembled on a disposable inserter.
The line extension of the Stryker XCEL Anchor System will be provided sterile for single-use (ASTM 4169). The device will be sterilized by Ethylene Oxide (ANSI/AAMI/ISO 11135), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10 °. The device is biocompatible per ISO-10993-1 and G95-1. The line extension of the Stryker XCEL Anchor System is substantially equivalent in material of construction, overall design, intended use, and safety and efficacy to the predicate device. The subject device was shown to have substantially equivalent performance when compared to the predicate device.
The line extension of the Stryker XCEL Anchor System is considered substantially equivalent to the Stryker XCEL Anchor System (#K023013).
Contact:
Date: May 6, 2004
Melissa Murphy Regulatory Representative Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 (408) 754-2148
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Image /page/1/Picture/1 description: The image shows a black and white seal for the Department of Health and Human Services - USA. The seal is circular, with the text "Department of Health & Human Services - USA" arranged around the perimeter. In the center of the seal is the department's logo, which features a stylized human figure with three arms raised upwards.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 4 2004
Ms. Melissa Murphy Regulatory Representative Stryker Endoscopy 5900 Optical Court San Jose, California 95138
Re: K041307
Trade/Device Name: Stryker XCEL Anchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Fastener, fixation, biodegradable, soft tissue Regulatory Class: II Product Code: MAI Dated: May 6, 2004 Received: May 17, 2004
Dear Ms. Murphy:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications ferenced above and nave determined ly marketed predicate devices marketed in interstate for use stated in the encrosale) to tegains and the Medical Device Amendments, or to commerce price to May 20, 1978, the excordance with the provisions of the Federal Food, Drug. devices mat have been recuire approval of a premarket approval application (PMA). alla Cosmetic Acr (71ct) that do not required to the general controls provisions of the Act. The 1 ou may, mercrore, market the act include requirements for annual registration, listing of general controls provisions of wastice, 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 If your device is classified (600 abs. of ols. Existing major regulations affecting your device can may oc subject to suell additions, Title 21, Parts 800 to 898. In addition, FDA may be futur in the Out of I cants concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri- 3 issualled of a cademice complies with other requirements of the Act that FDA has made a dolorimiation administered by other Federal agencies. You must of any I cuttar statutes and regaranents and with the timited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Fart 607), ademig (21 OFR Part 820); and If applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Melissa Murphy
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manoling your article quivalence of your device to a legally premarket notification. The PDA midning of backander of ...
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 il you desire specific advice for your ac 110 %. 6.59. Also, please note the regulation entitled, provinces and Contact the Office of Complanes as (Set notification" (21CFR Part 807.97). You may obtain " Misoranding by release to premants. Iousliteans in the Act from the Division of Small other general information on your response at its toll-free number (800) 638-2041 or Manufacturers, International and Golless 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): K04130Z
Device Name: Stryker XCEL Anchor System
Indications For Use: The Stryker XCEL Anchor System is intended for use in securing soft tissue to bone in such procedures as:
| Shoulder: | Elbow: |
|---|---|
| Bankart repair | Biceps tendon reattachment |
| SLAP lesion repair | Foot & Ankle: |
| Rotator cuff repair | Achilles tendon repair/reconstruction |
| Capsular shift repair | Lateral stabilization |
| Biceps tenodesis | Medial stabilization |
| Acromio-clavicular separation | |
| Knee: | |
| Medial collateral ligament repair | |
| Lateral collateral ligament repair | |
| Joint capsule closure to anterior proximal tibia | |
| Posterior oblique ligament or joint capsule to tibia repair | |
| Extra capsular reconstruction/ITB tenodesis |
Patellar ligament and tendon avulsion repairs
The Stryker XCEL Anchor System is intended for single-use only.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
Miriam C. Provost
(Division Sign-Off) (Division Sign organ oral, Restorative, and Neurological Devices
510(k) Number_K041307_________________________________________________________________________________________________________________________________________________________
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.