(36 days)
No
The device description and performance studies focus on the mechanical properties and materials of a threaded anchor system for surgical fixation, with no mention of AI or ML capabilities.
Yes
The device is described as an "anchor system" intended for "fixation of suture (soft tissue) to bone" in various parts of the body, which directly relates to treating injuries or conditions.
No
The ecoFIX® threaded anchor system is designed for fixation of suture to bone during surgical repairs (e.g., rotator cuff repair, ACL repair). It is a medical implant used for treatment, not for identifying or diagnosing a medical condition.
No
The device description clearly states that the ecoFIX® is a threaded anchor system made of physical materials (composite bioabsorbable material and sutures) and is supplied with a reusable screwdriver. This indicates it is a physical medical device, not software-only.
Based on the provided information, the ecoFIX® threaded anchor system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "fixation of suture (soft tissue) to bone" in various anatomical locations. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "threaded anchor system" made of bioabsorbable material and sutures. This is a physical implant used during surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The ecoFIX® system does not perform any such function.
Therefore, the ecoFIX® threaded anchor system is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ecoFIX® threaded anchor system is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, the following procedures:
Shoulder: Rotator Cuff Repair; SLAP Lesion Repair; Biceps Tenodesis; Acromio-clavicular Separation Repair; Deltoid Repair; Capsule Shift or Capsulolabral Reconstruction;
Ankle/Foot: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy
Knee: Anterior Cruciate Ligament Repair; Medial Collateral Ligament Repair; Ligament Repair; Patellar Tendon Repair; Posterior Oblique Ligament Repair; Iliotibial Band Tenodesis;
Wrist/Hand: Scapholunate Ligament Reconstruction; Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment; Ulnar or Radial Collateral Ligament Reconstruction; Tennis Elbow Repair and Lateral Epicondylitis Repair.
Product codes
MAI
Device Description
ecoFIX® is an extension the FIXIT® / ComposiTCP™ threaded anchor system previously cleared by the FDA (K170868 & K180960). ecoFIX® is a threaded anchor system which comprises an anchor made of DUOSORB® 30, a composite bioabsorbable material composed of 30 % Beta-tricalcium phosphate (ß-ΤCP) and 70 % Poly L,DL-lactic acid (PLDLLA), and sutures made of ultra-high molecular weight polyethylene (UHMWPE). Different variants of the product are available depending on the number and type of suture combination (2 round sutures, 2 round needled sutures, 3 round sutures, or knotless anchor).
The implant is supplied sterile, ready to use.
The implant is available in the following configurations, supplied with a reusable screwdriver:
· ecoFIX®: hexagonal footprint anchor (3 sizes Ø4.5, Ø5.5, Ø6.5) suppplied in an implant holder with 2 round sutures ;
- · ecoFIX® Needle: hexagonal footprint anchor (3 sizes Ø4.5, Ø6.5) supplied in an implant holder with 2 round needled sutures ;
· ecoFIX® +: hexagonal footprint anchor (1 size Ø5.5) supplied in implant holder with 3 round sutures ;
· ecoFIX® Band: hexagonal footprint anchor (3 sizes Ø4.5, Ø5.5, Ø6.5) supplied in an implant holder with 2 flat sutures ;
· ecoFIX® Knotless: hexagonal footprint anchor (3 sizes Ø4.5, Ø5.5) supplied in an implant holder.
- MATERIALS
Implant(s) : - Anchor: DUOSORB®30 (30% ß-TCP / 70% PLDLLA)
- Sutures:
o Blue and white sutures: Ultra-high molecular weight polyethylene (UHMWPE)
o White/black suture: UHMWPE + black polyamide (nylon) monofilament o Needle : stainless steel and medical grade silicone coating
Implant holder: - Polyamide
Reusable screwdriver:
-
Screwdriver handle: Silicone / Polycarbonate
-
Screwdriver shaft: Stainless steel (304L)
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)
Non-clinical performance testing:
Non-clinical testing including biocompatibility, biological and mechanical performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use and equivalent to the predicate devices. Bacterial endotoxin testing has been completed and results have demonstrated that the proposed devices meet the endotoxin limits.
Clinical performance testing:
Clinical performance data was not included.
Performance tests were carried out to evaluate the ease of use, driver hold, needle hold and the insertion, pullout/slippage performances of the ecoFIX® range of devices. The results demonstrated that the subject device is substantially equivalent to its predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
July 26, 2023
Science & Bio materials (S.B.M.) SAS Anne Cospin Ouality and Regulatory Affairs Director Zi Du Monge Lourdes, 65100 France
Re: K231787
Trade/Device Name: ecoFIX® Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: MAI Dated: June 20, 2023 Received: June 20, 2023
Dear Ms. Cospin:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jesse Muir -S
Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
ecoFIX®
Indications for Use (Describe)
The ecoFIX® threaded anchor system is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, the following procedures:
Shoulder: Rotator Cuff Repair; SLAP Lesion Repair; Biceps Tenodesis; Acromioclavicular Separation Repair; Deltoid Repair; Capsule Shift or Capsulolabral Reconstruction; Ankle/Foot: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Bunionectorny Knee: Anterior Cruciate Ligament Repair; Medial Collateral Ligament Repair; Lateral Collateral Ligament Repair; Patellar Tendon Repair; Posterior Oblique Ligament Repair; Iliotibial Band Tenodesis:
Wrist/Hand: Scapholunate Ligament Reconstruction; Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment; Ulnar or Radial Collateral Ligament Reconstruction; Tennis Elbow Repair and Lateral Epicondylitis Repair.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary 510(k) #: K231787 Prepared on: 2023-07-21 Contact Details 21 CFR 807.92(a)(1) SCIENCE & BIO MATERIALS (S.B.M.) SAS Applicant Name Applicant Address ZI DU MONGE LOURDES 65100 France Applicant Contact Telephone 33562422101 Applicant Contact Mrs. Anne COSPIN Applicant Contact Email anne.cospin@sbm-fr.com Device Name 21 CFR 807.92(a)(2) ecoFIX® Device Trade Name Single/multiple component metallic bone fixation appliances and Common Name accessories Classification Name Fastener, Fixation, Biodegradable, Soft Tissue Regulation Number 888.3030 Product Code MAI Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate Trade Name (Primary Predicate is listed first) Predicate # Product Code FIXIT® / ComposiTCP™ Threaded Anchor System K180960 MAI K170868 FIXIT® / ComposiTCP™ Threaded Anchor System MAI Device Description Summary 21 CFR 807.92(a)(4) 1. DEVICE DESCRIPTION
ecoFIX® is an extension the FIXIT® / ComposiTCP™ threaded anchor system previously cleared by the FDA (K170868 & K180960). ecoFIX® is a threaded anchor system which comprises an anchor made of DUOSORB® 30, a composite bioabsorbable material composed of 30 % Beta-tricalcium phosphate (β-ΤCP) and 70 % Poly L,DL-lactic acid (PLDLLA), and sutures made of ultra-high molecular weight polyethylene (UHMWPE). Different variants of the product are available depending on the number and type of suture combination (2 round sutures, 2 round needled sutures, 3 round sutures, or knotless anchor).
The implant is supplied sterile, ready to use.
The implant is available in the following configurations, supplied with a reusable screwdriver:
· ecoFIX®: hexagonal footprint anchor (3 sizes Ø4.5, Ø5.5, Ø6.5) suppplied in an implant holder with 2 round sutures ;
- · ecoFIX® Needle: hexagonal footprint anchor (3 sizes Ø4.5, Ø6.5) supplied in an implant holder with 2 round needled sutures ;
· ecoFIX® +: hexagonal footprint anchor (1 size Ø5.5) supplied in implant holder with 3 round sutures ;
· ecoFIX® Band: hexagonal footprint anchor (3 sizes Ø4.5, Ø5.5, Ø6.5) supplied in an implant holder with 2 flat sutures ;
· ecoFIX® Knotless: hexagonal footprint anchor (3 sizes Ø4.5, Ø5.5) supplied in an implant holder.
- MATERIALS
Implant(s) : - Anchor: DUOSORB®30 (30% ß-TCP / 70% PLDLLA)
- Sutures:
o Blue and white sutures: Ultra-high molecular weight polyethylene (UHMWPE)
4
2/3
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
The indications for use of the submitted device are the ones of the predicate devices.
Posterior Oblique Ligament Repair; Iliotibial Band Tenodesis;
Wrist/Hand: Scapholunate Ligament Reconstruction; Unar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament
Elbow: Biceps Tendon Reattachment; Unar or Radial Collateral Ligament Reconstruction; Tennis Elbow Repair and Lateral Epicondylitis
Indications for Use Comparison
Intended Use/Indications for Use
The ecoFIX® threaded anchor system is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, the following procedures:
Shoulder: Rotator Cuff Repair; SLAP Lesion Repair; Biceps Tenodesis; Acromio-clavicular Separation Repair; Deltoid Repair; Capsule Shift or Capsulolabral Reconstruction;
Ankle/Foot: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy
Knee: Anterior Cruciate Ligament Repair; Medial Collateral Ligament Repair; Ligament Repair; Patellar Tendon Repair;
Reconstruction.
Repair.
- PERFORMANCE DATA
Non-clinical performance testing:
Non-clinical testing including biocompatibility, biological and mechanical performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use and equivalent to the predicate devices. Bacterial endotoxin testing has been completed and results have demonstrated that the proposed devices meet the endotoxin limits.
Clinical performance testing:
Clinical performance data was not included.
- SUBSTANTIAL EQUIVALENCE
The modifications to FIXT® Threaded Anchor System (K170868 & K180960) consist of additional variants eco-designed with the aim of limiting waste in the operating room by using a reusable rather than a single-use screwdriver.
The additional ecoFIX® Threaded Anchor System is substantially equivalent to its predicate device FIXIT® Threaded Anchor System (K170868 & K180960) in terms of intended use, material, design, mechanical properties and function.
and effectiveness and have no apparent effect on the performance, function, or intended use of this device.
Bacterial endotoxin testing has been completed and results have demonstrated that the proposed devices meet the endotoxin limits.
Clinical performance data was not inclu
limiting waste in the operating room by using a reusable rather than a single-use screwdriver.
The additional ecoFIX® Threaded Anchor System is substantially equivalent to its predicate device FIXIT® Threaded Anchor System
The additional ecoFIX® Threaded Anchor System is substantially equivalent to its predicate device FIXIT® Threaded Anchor Syst
(K170868 & K180960) in terms of intended use, material, design, mechanical properties and function.
Minor differences between the ecoFIX® threaded anchor system and the predicate do not raise any questions concerning safety
Capsule Shift or Capsulolabral Reconstruction;
Ankle/Foot: Lateral Stabilization, Medial Stabilization, Achilles T
Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee: Anterior Cruciate Ligament Repair; Medial Collateral Ligament Repair; Ligament Repair; Patellar Tendon Repair;
Wrist/Hand: Scapholunate Ligament Reconstruction; Unar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament
Reconstruction. Elbow: Biceps Tendon Reattachment; Unar or Radial Collateral Ligament Reconstruction; Tennis Elbow Repair and Lateral Epicondylitis
o White/black suture: UHMWPE + black polyamide (nylon) monofilament o Needle : stainless steel and medical grade silicone coating
Implant holder: - Polyamide
Reusable screwdriver:
-
Screwdriver handle: Silicone / Polycarbonate
-
Screwdriver shaft: Stainless steel (304L)
3. INDICATIONS FOR USE
The ecoFlX® threaded anchor system is intended for fixation of suture (soft tissue) to bone in the shoulder, foot ankle, knee, hand/wrist, and elbow, the following procedures:
Shoulder: Rotator Cuff Repair; SLAP Lesion Repair; Biceps Tenodesis; Acromio-clavicular Separation Repair; Deltoid Repair; Capsule Shift or Capsulolabral Reconstruction;
Ankle/Foot: Lateral Stabilization, Medial Stabilization, Achiles Tendon Repair, Hallux Valgus Reconstruction,
Posterior Oblique Ligament Repair; Iliotibial Band Tenodesis;
Wrist/Hand: Scapholunate Ligament Reconstruction; Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament
Reconstruction.
Repair.
5
Technological Comparison
21 CFR 807.92(a)(6)
The modifications to FIXT® Threaded Anchor System (K170868 & K180960) consist of additional variants eco-designed with the aim of limiting waste in the operating room by using a reusable rather than a single-use screwdriver.
The additional ecoFIX® Threaded Anchor System is substantially equivalent to its predicate device FIXIT® Threaded Anchor System (K170868 & K180960) in terms of intended use, material, design, mechanical properties and function.
Minor differences between the ecoFIX® threaded anchor system and the predicate do not raise any questions concerning safety and effectiveness and have no apparent effect on the performance, function, or intended use of this device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Performance tests were carried out to evaluate the ease of use, driver hold, needle hold and the insertion, pullout/slippage performances of the ecoFIX® range of devices. The results demonstrated that the subject device is substantially equivalent to its predicate device.