(85 days)
The Foundry NewcoXI Cincher-2.6 Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:
Hip
- Hip capsule repair
- Acetabular labrum reattachment
Shoulder
- Capsular stabilization
- Bankart repair
- Anterior shoulder instability
- SLAP lesion repairs
- Capsular shift or capsulolabral reconstructions
- Acromioclavicular separation repairs
- Deltoid repairs
- Rotator cuff tear repairs
- Biceps tenodesis
Foot and Ankle
- Hallux valgus repairs
- Medial or lateral instability repairs/reconstructions
- Achilles tendon repairs/reconstructions
- Midfoot reconstructions
- Metatarsal ligament/tendon repairs/reconstruction
- Bunionectomy
Elbow, Wrist and Hand
- Bicens tendon reattachment
- Ulnar or radial collateral ligament reconstructions
- Lateral epicondylitis repair
- Tennis elbow repair
- Scapholunate ligament reconstruction
Knee
- Extra-capsular repairs:
- Medial collateral ligament
- Lateral collateral ligament
- Posterior oblique ligament
- Patellar realignment and tendon repairs Vastus medialis obliquous advancement
- Iliotibial band tenodesis
The Foundry NewcoXI Cincher-2.6 Suture Anchor is intended for single-use only.
The Cincher-2.6 Suture Anchor consists of a PEEK polymer suture anchor preloaded with a #2 polyethylene suture, loaded on an insertion tool. The Cincher-2.6 Suture Anchor is designed to facilitate fixation of soft tissue to bone. The design allows the surgeon to adjust the suture tension on the soft tissue after insertion of the anchor into bone. The device is provided sterile.
The provided text describes the Cincher-2.6 Suture Anchor, a medical device for soft tissue fixation to bone. The information primarily focuses on its substantial equivalence to predicate devices and results from non-clinical bench testing.
Based on the provided text, here's an analysis of the acceptance criteria and study information:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from the FDA Guidance Document for Testing Bone Anchor Devices (dated April 20, 1996) and focus on mechanical performance.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Static Anchor Pull Out Strength | Met design specifications |
| Static Anchor Pull Out Displacement | Met design specifications |
| Pull Out Strength After Cyclic Loading | Met design specifications |
| Biocompatibility | Substantially equivalent to predicate devices (implied to meet standards) |
| Packaging | Substantially equivalent to predicate devices (implied to meet standards) |
| Sterilization | Substantially equivalent to predicate devices (implied to meet standards) |
| Labeling | Substantially equivalent to predicate devices (implied to meet standards) |
Study Proving Acceptance Criteria:
A series of non-clinical bench studies were conducted to evaluate the anchor performance. These studies demonstrated that the Cincher-2.6 Suture Anchor meets the design specifications for the listed performance criteria.
2. Sample Size and Data Provenance
- Sample Size for Test Set: Not specified in the provided document. The text only mentions "bench studies" without detailing the number of units tested.
- Data Provenance: The studies were non-clinical bench tests. The country of origin of the data is not explicitly stated, but the submission is to the US FDA by a company with a US address, suggesting the testing was likely conducted in the US or under US regulatory standards. The data is not applicable as retrospective or prospective since it refers to device testing, not patient data.
3. Number and Qualifications of Experts for Ground Truth
- This section is not applicable. The studies described are non-clinical bench tests evaluating the mechanical properties of a device, not studies involving interpretation of data by human experts for establishing ground truth as would be relevant for an AI/CAD device.
4. Adjudication Method
- This section is not applicable for the same reasons as point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. This type of study is relevant for AI/CAD devices assessing human performance with and without AI assistance, which is not the nature of this medical device.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone algorithm performance study was not conducted or described. This device is a physical medical implant, not an AI algorithm. The performance described is the standalone mechanical performance of the physical device itself.
7. Type of Ground Truth Used
- The "ground truth" for the non-clinical bench studies was based on engineering specifications and recognized test standards outlined in the FDA Guidance Document for Testing Bone Anchor Devices. This means the performance was measured against predefined acceptable ranges and thresholds for mechanical properties (e.g., minimum pull-out strength, maximum displacement).
8. Sample Size for the Training Set
- This section is not applicable. The device is a physical suture anchor, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- This section is not applicable for the same reasons as point 8.
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Attachment 3: 510(k) Summary (per 21 CFR 807.92)
DEC 1 9 2012
| Submitter Name and Address | ||
|---|---|---|
| Name: | Foundry NewcoXI Inc. | |
| Contact: | Michael Kolber | |
| Regulatory Affairs Consultant | ||
| Address: | 199 Jefferson Drive | |
| Menlo Park, CA 94025 | ||
| Telephone: | 408-505-6626 | |
| Fax: | 650-326-3108 | |
| Date Prepared: | December 3, 2012 | |
| General Device Information | ||
| Product Name: | Cincher-2.6 Suture Anchor | |
| Common Name: | Suture Anchor | |
| Classification: | 21 CFR 888.3040 | |
| Smooth or threatened metallic bone fixation fastener | ||
| Device Class: | Class: II | |
| Product Code: | MBI | |
| Predicate Devices | ||
| Manufacturer | Device Name | 510(k) Number |
| Smith & Nephew, Inc. | BIORAPTOR 2.3 PK | K071586 |
| Arthrex, Inc. | PushLock | K061863 |
| Teleflex Medical, Inc. | Force Fiber | K063778 |
| Description | ||
| The Cincher-2.6 Suture Anchor consists of a PEEK polymer suture anchor preloaded with | ||
| a #2 polyethylene suture, loaded on an insertion tool. The Cincher-2.6 Suture Anchor is | ||
| designed to facilitate fixation of soft tissue to bone. The design allows the surgeon to | ||
| adjust the suture tension on the soft tissue after insertion of the anchor into bone. The | ||
| device is provided sterile. |
Page 1 of 2
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Intended Use (Indications)
The Cincher-2.6 Suture Anchor is intended to be used for soft tissue fixation to bone in the hip, shoulder, foot, ankle, elbow, wrist, hand, and knee. The anchor is intended for use in the following procedures:
Hip
- · Hip capsule repair
- -
Shoulder
- · Capsular stabilization
- Bankart repair ।
- Anterior shoulder instability ।
- SLAP lesion repairs I
- । Capsular shift or capsulolabral reconstructions
- Acromioclavicular separation repairs
- . Deltoid repairs
- Rotator cuff tear repairs .
- Biceps tenodesis
Foot and Ankle
- · Hallux valgus repairs
- Medial or lateral instability repairs/reconstructions
- Achilles tendon repairs/reconstructions
- · Midfoot reconstructions
- . Metatarsal ligament/tendon repairs/reconstruction
- Bunionectomy
Comparison to the Predicate Devices
The Cincher-2.6 Suture Anchor has a similar intended use and fundamental technology as the Smith & Nephew, Inc. BIORAPTOR 2.3 PK and the Arthrex, Inc. PushLock predicate devices. The technological characteristics of the Cincher-2.6 Suture Anchor are substantially equivalent to the predicate devices including biocompatibility, bench testing, packaging, sterilization, and labeling. Through bench testing it was demonstrated that the modified design do not adversely affect the safety and effectiveness.
Summary of Non-clinical and Clinical Testing
The non-clinical test data in this submission demonstrated that the Cincher-2.6 Suture Anchor meets the performance specifications. The 510(k) notice contains summaries of bench studies that were conducted to evaluate the anchor performance as specified in the FDA Guidance Document for Testing Bone Anchor Devices (dated April 20, 1996), The testing demonstrated that the Cincher-2.6 Suture Anchor meets the design specifications with respect to Static Anchor Pull Out Strength and Displacement and Pull Out Strength After Cyclic Loading.
Statement of Equivalence
The Foundry NewcoXI Cincher-2.6 Suture Anchor has a similar indications for use and technological characteristics as the predicate devices. Based on this and the data provided in this premarket notification, the Cincher-2.6 Suture Anchor and the predicate devices have been shown to be substantially equivalent.
Elbow. Wrist and Hand
- · Biceps tendon reattachment
- Ulnar or radial collateral ligament reconstructions
- Lateral cpicondylitis repair
- · Tennis elbow repair
- Scapholunate ligament reconstruction
Knee
- · Extra-capsular repairs:
- Medial collateral ligament
- Lateral collateral ligament
- Posterior oblique ligament t
- Patellar realignment and tendon repairs Vastus medialis obliquous advancement ।
- · Iliotibial band tenodesis
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Leter dated: December 19, 2012
Foundry Newco Xi % Mr. Michael Kolber 14734 La Rinconada Drive Los Gatos, California 95032
Re: K122954
Trade/Device Name: Cincher-2.6 Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: September 24, 2012 Received: September 25, 2012
Dear Mr. Kolber:
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. 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 either 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 comply with all the Act's requirements, 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 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 - Mr. Michael Kolber
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Foundry NewcoXI
Attachment 1: Indications for Use Statement
Indications for Use
510(k) Number (if known): K122954
Device Name: Cincher-2.6 Suture Anchor
Indications for Use: The Foundry NewcoXI Cincher-2.6 Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:
Hip
- Hip capsule repair .
- Acetabular labrum reattachment
Shoulder
-
Capsular stabilization .
- l Bankart repair
- | Anterior shoulder instability
- SLAP lesion repairs -
- Capsular shift or capsulolabral reconstructions ー
-
Acromioclavicular separation repairs ■
-
Deltoid repairs .
-
Rotator cuff tear repairs a
-
미 Biceps tenodesis
· Foot and Ankle
- Hallux valgus repairs .
- Medial or lateral instability repairs/reconstructions b
- Achilles tendon repairs/reconstructions l
- . Midfoot reconstructions
- Metatarsal ligament/tendon repairs/reconstruction I
- Bunionectomy ●
Elbow, Wrist and Hand
- Bicens tendon reattachment .
- Ulnar or radial collateral ligament reconstructions
- . Lateral epicondylitis repair
- Tennis elbow repair .
- Scapholunate ligament reconstruction
Knee
- Extra-capsular repairs: ■
- Medial collateral ligament ー
- Lateral collateral ligament -
- ー Posterior oblique ligament
- Patellar realignment and tendon repairs Vastus medialis obliquous advancement -
- lliotibial band tenodesis
The Foundry NewcoXI Cincher-2.6 Suture Anchor is intended for single-use only.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
(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)
Casey Hanley
For Division of Orthopaedic Devices
Over-The-Counter Use
. .
N/A