(127 days)
No
The device description and intended use focus on a mechanical implant for soft tissue fixation, with no mention of AI or ML capabilities.
Yes
The device is described as an "orthopedic implant intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon bone," indicating it is used for medical treatment and restoration of function.
No
The device is an orthopedic implant for fixing soft tissue to bone, not for diagnosing medical conditions.
No
The device description clearly states it is a physical orthopedic implant made of PEEK, intended for surgical fixation of soft tissue to bone. 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, or tissue) to provide information about a person's health.
- Device Description: The MedShape, Inc., Eclipse™ Soft Tissue Fastener is described as a sterile, single-use, orthopedic implant intended for the fixation of soft tissue to bone. It is a physical device implanted into the body during surgery.
- Intended Use: The intended use clearly outlines surgical procedures where the device is used to attach soft tissue to bone within the body.
The device's function is to provide mechanical support and fixation within the body, not to analyze biological samples outside the body.
N/A
Intended Use / Indications for Use
The Eclipse™ Soft Tissue Fastener is indicated for fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in the following procedures:
- Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Tenodesis, Acromio-Clavicular Separation Biceps Repair. Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair. Hallux Valgus Reconstruction. Mid-foot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Anchiles Tendon Reconstruction and Tendon Transfers
- Knee: Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulmar Collateral Collateral Ligament Reconstruction, Radial Ligament Reconstruction, Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and Repairs and Tendon Transfers
- Elbow: Biceps Tendon Reattachment and Ulnar or Radial collateral Ligament Reconstruction
Product codes
MBI, GAT
Device Description
The proposed Eclipse™ Soft Tissue Fastener is a sterile, single use, orthopedic implant intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon bone. The Eclipse™ Soft Tissue Fastener is designed to use the principles of interference fit to reattach soft tissue intended for insertion into a hole created in bone.
The Eclipse™ Soft Tissue Fastener body is comprised of an implant grade PEEK sleeve and implant grade PEEK insert. The outer sleeve is expanded into the bone hole, compressing the soft tissue aqainst the bone wall; fastening it into place.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, foot/ankle, knee, hand/wrist and elbow
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
functional performance testing has been conducted in Sawbone® bone analoque. This testing included monotonic soft tissue fixation strength (pull-to-failure) and other dimensional verification and material safety testing (both bio and MRI compatibility). Analysis of the results supports the conclusion that the proposed device is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Arthrex® Tenodesis Screws, K051726, MedShape, Inc., ExoShape® Soft Tissue Anchor, K101808
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K123350 (1/2)
Image /page/0/Picture/1 description: The image shows the logo for MedShape. The logo consists of a stylized letter "M" with a square on top and the word "MEDSHAPE" to the right of the letter. The text is in a blocky, sans-serif font.
MAR 7 2013
Traditional 510(k) Page 10 of 124
510(k) Summary
January 23td, 2013 Date Submitted:
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(e).
- A. Submitter: MedShape, Inc. 1575 Northside Drive, Suite 440 Atlanta, Georgia 30318
- B. Company Contact: Jack Griffis Vice President. Research & Development (678) 235-3311 (direct) (404) 249-9158 (fax) jack.griffis@medshape.com
| C. | Device Information:
Trade Name(s): | Eclipse™ Soft Tissue Fastener with (optional) pre-
loaded ForceFiber® Sutures |
|----|---------------------------------------|---------------------------------------------------------------------------------------------|
| | Common Name(s): | Fastener, Fixation, bone, non-degradable
Suture, Non-absorbable, Synthetic, Polyethylene |
| D. | Classification Name: | Fastener, Fixation, Non-degradable, Soft Tissue
HWC/MBI 21 CFR 888.3040 |
| | | Suture, Non-absorbable, Synthetic, Polyethylene
GAT 21 CFR 878.500 |
- E. Predicate Device(s): Arthrex® Tenodesis Screws, K051726 MedShape, Inc., ExoShape® Soft Tissue Anchor, K101808
ட் Physical Description:
The proposed Eclipse™ Soft Tissue Fastener is a sterile, single use, orthopedic implant intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon bone. The Eclipse™ Soft Tissue Fastener is designed to use the principles of interference fit to reattach soft tissue intended for insertion into a hole created in bone.
The Eclipse™ Soft Tissue Fastener body is comprised of an implant grade PEEK sleeve and implant grade PEEK insert. The outer sleeve is expanded into the bone hole, compressing the soft tissue aqainst the bone wall; fastening it into place.
1
-
G. Indications for Use:
The Eclipse™ Soft Tissue Fastener is indicated for fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in the following procedures: -
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Tenodesis, Acromio-Clavicular Separation Biceps Repair. Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
-
Lateral Stabilization, Medial Stabilization, Achilles Tendon Foot/Ankle: Repair. Hallux Valgus Reconstruction. Mid-foot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Anchiles Tendon Reconstruction and Tendon Transfers
-
Knee: Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
-
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulmar Collateral Collateral Ligament Reconstruction, Radial Ligament Reconstruction, Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and Repairs and Tendon Transfers
-
Biceps Tendon Reattachment and Ulnar or Radial collateral Elbow: Ligament Reconstruction
-
H. Comparison of Technological Characteristics:
The Eclipse™ Soft Tissue Fastener is substantially equivalent in function and intended use to the following predicate devices:
Arthrex® Tenodesis Screws, K051726 MedShape, Inc., ExoShape® Soft Tissue Anchor, K101808
All fasteners are comprised of implant grade PEEK. All fasteners have the same indications for use. In addition, functional performance testing has been conducted in Sawbone® bone analoque. This testing included monotonic soft tissue fixation strength (pull-to-failure) and other dimensional verification and material safety testing (both bio and MRI compatibility). Analysis of the results supports the conclusion that the proposed device is substantially equivalent to the predicate devices.
1/23/13
Jáck Griffis Vice President, Research & Development
Image /page/1/Picture/14 description: The image shows the logo for Medshape. The logo consists of a stylized letter "a" with a square on top, followed by the word "MEDSHAPE" in block letters. The logo is black and white and appears to be a company logo.
1575 Northside Drive, Suite 440 Atlanta, GA 30318 877-343-7016 phone 404-249-9158 fax
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three faces in profile, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 7, 2013
MedShape, Incorporated % Mr. Jack Griffis Vice President, Research and Development 1575 Northside Drive Northwest, Suite 440 Atlanta, Georgia 30318
Re: K123350
Trade/Device Name: Eclipse™ Soft Tissue Fastener Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, GAT Dated: January 24, 2013 Received: February 4, 2013
Dear Mr. Griffis:
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
3
Page 2 - Mr. Jack Griffis
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.
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/CDRH/CDRHOffices/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Ering Deith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: _ 123350
Device Name: Eclipse™ Soft Tissue Fastener
Indications for Use:
The MedShape, Inc., Eclipse™ Soft Tissue Fastener is intended for fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist and elbowing procedures:
- Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Anchiles Tendon Reconstruction and Tendon Transfers
- Knee: Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty), Carpal Liqament Reconstructions and Repairs and Tendon Transfers
- Elbow: Biceps Tendon Reattachment and Ulnar or Radial collateral Ligament Reconstruction
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
R Over-The-Counter
(21 CFR 801.9)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Casey L. Hanley, Ph.D.
Division of Orthopaedic Devices