(202 days)
No
The summary describes a physical fixation device made of a specific biomaterial. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a fixation device intended for soft tissue reattachment in various surgical procedures, which is a therapeutic function.
No
Explanation: The device is described as a "fixation device" intended for "soft tissue reattachment" in surgical procedures, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical fixation device made from a biomaterial, intended for surgical implantation. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical fixation of soft tissue to bone. This is a mechanical function performed in vivo (within the body) during surgery.
- Device Description: The description details a physical implantable device (screws and a self-locking device) made of a biomaterial. This is consistent with a surgical implant, not a diagnostic test performed in vitro (outside the body).
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) to diagnose a condition, monitor a disease, or screen for health issues.
- Performance Studies: The performance studies focus on the device's physical properties, biocompatibility, degradation, and functional performance in animal models of surgical procedures. These are relevant to an implantable surgical device, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This device is a surgical tool and implant used to physically repair injuries.
N/A
Intended Use / Indications for Use
The Citregen Tendon Interference Screw (TIS) and Citrelock are intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. More specifically:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tendon Reattachment, Acromion-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization. Achilles Tendon Repair. Hallux Valqus Reconstruction. Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle.
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis,
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist.
Product codes
MAI
Device Description
The Citregen TIS and Citrelock are fixation devices ranging in diameter from 4 to 9 mm and lengths from 10 to 23 mm to be used with reusable instruments. There are two designs for the system: 1) a traditional tapered, blunt threaded and cannulated screw that is screwed into the prepared bone and 2) a "twist-ribbed" cannulated, self-locking device (trade named Citrelock™) that is inserted into bone. The Citregen TIS and Citrelock system is intended to attach soft tissue to bone for procedures in the foot/ankle, knee, shoulder, elbow, and hand/wrist.
The Citregen TIS and Citrelock are made from Citregen biomaterial, which is a homogeneous biocomposite comprised of 60 wt.-% unsintered hydroxvapatite (HA) and 40 wt.-% polyester. Citregen's polymer component is a citrate-based network of completely amorphous polymer chains crosslinked together to form an elastomeric material. As water penetrates the subject device, surface erosion of the polymer phase occurs through hydrolysis of the ester bonds located between the monomers and at the crosslink sites.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, elbow, foot/ankle, knee, hand/wrist
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)
The performance characteristics of the Citregen TIS and Citrelock were established via comprehensive studies of packaging, shelf life testing, physical and chemical properties per ASTM F2902, biocompatibility tests per ISO 10993, lifecycle evaluation in GLP rabbit studies, functional performance in vitro, and functional performance in a GLP ovine model of ACL fixation. Biocompatibility evaluation included analysis of extractables and leachables data, in accordance with ISO 10993-18, as the basis for individual Toxicological Risk Assessments at three points along the implant degradation lifecycle, 0, ~25% and ~87%, in lieu of longer term in-vivo data to that same extent of degradation.
Packaging and shelf life tests using real- and accelerated time aging were performed with passing results. Bacterial endotoxin testing showed the Citregen TIS to meet the set endotoxin limits. The biocompatibility of Citregen devices was demonstrated by full panel ISO 10993 testing for a permanent implant and toxicological risk assessment, which includes the long clinical history of unsintered HA and the innate presence of citrate in bone. Biocompatibility studies performed with Citregen devices at various stages of polymer hydrolysis in a GLP rabbit bone implantation model demonstrated biocompatibility with no chronic inflammation at 4, 13, and 26 weeks per ISO 10993-6. E&L testing at various stages of polymer hydrolysis was also performed.
The Citregen TIS and Arthrex predicate devices were evaluated in a GLP functional ovine model of ACL reconstruction for 0, 3-, 6-, and 12-month time points, per ISO 10993-6. The performance characteristics of subject and predicate devices were evaluated using imaging, histological, histomorphometry, and biomechanical data. The results of the study through 12 months demonstrated that the Citregen TIS performance was substantially equivalently to the predicate device.
The Citregen TIS and Arthrex predicate devices were further evaluated in a GLP functional ovine model of ACL reconstruction for 24-months, via imaging studies and inlife assessment. The results of in vitro E&L analysis, toxicological risk assessment and the histology, histomorphometry, and imaging studies through 24 months in vivo demonstrated that the Citregen TIS and Citrelock performance was substantially equivalently to the 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
October 7, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
Acuitive Technologies % Janice Hogan Partner Hogan Lovells US. LLP 1735 Market Street Philadelphia, Pennsylvania 19103
Re: K200725
Trade/Device Name: Citregen Tendon Interference Screw and Citrelock 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: September 3, 2020 Received: September 3, 2020
Dear Ms. Hogan:
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,
Laura C. Rose, 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
510(k) Number (if known)
Citregen Tendon Interference Screw (TIS) and Citrelock
Device Name
K200725
Indications for Use (Describe)
The Citregen Tendon Interference Screw (TIS) and Citrelock are intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. More specifically:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tendon Reattachment, Acromion-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization. Achilles Tendon Repair. Hallux Valqus Reconstruction. Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle.
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis,
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist.
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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K200725 SUMMARY – Citregen Tendon Interference Screw and Citrelock
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following information is a summary of safety and effectiveness of Citregen Tendon Interference Screw and Citrelock.
A. SUBMITTERS INFORMATION
| Submitter Name: | Hogan Lovells, US LLP. |
|---|---|
| Submitter Address: | 1735 Market Street, Suite 2300, Philadelphia, PA 19103 |
| Contact Person: | Janice Hogan |
| Phone Number: | 267-675-4600 |
| Fax Number: | 267-675-4601 |
| Date of Submission: | October 6, 2020 |
B. DEVICE IDENTIFICATION & MANUFACTURER
| Manufacturer Name: | Acuitive Technologies, Inc. |
|---|---|
| Manufacturer Address: | 50 Commerce Drive, Allendale, NJ 07401, USA |
| Contact Name: | Jaclyn Docs |
| Title: | Director, Quality and Regulatory Affairs |
| Device Trade Name: | Citregen Tendon Interference Screw and Citrelock |
| Classification Name: | Single/multiple component metallic bone fixation appliances |
| and accessories (21 C.F.R. § 888.3030) | |
| Classification Code: | MAI |
| Classification Panel: | Orthopedic |
| Regulation Number: | 21 C.F.R. § 888.3030 |
| Manufacturer Name: | Acuitive Technologies, Inc. |
| Manufacturer Address: | 50 Commerce Drive, Allendale, NJ 07401, USA |
| Contact Name: | Jaclyn Docs |
C. PRIMARY PREDICATE DEVICE
| K051726 | Arthrex Tenodesis Family |
|---|---|
| --------- | -------------------------- |
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D. Indications for Use
The Citregen Tendon Interference Screw (TIS) and Citrelock are intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. More specifically:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tendon Reattachment, Acromion-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle.
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist.
E. Device Description
The Citregen TIS and Citrelock are fixation devices ranging in diameter from 4 to 9 mm and lengths from 10 to 23 mm to be used with reusable instruments. There are two designs for the system: 1) a traditional tapered, blunt threaded and cannulated screw that is screwed into the prepared bone and 2) a "twist-ribbed" cannulated, self-locking device (trade named Citrelock™) that is inserted into bone. The Citregen TIS and Citrelock system is intended to attach soft tissue to bone for procedures in the foot/ankle, knee, shoulder, elbow, and hand/wrist.
The Citregen TIS and Citrelock are made from Citregen biomaterial, which is a homogeneous biocomposite comprised of 60 wt.-% unsintered hydroxvapatite (HA) and 40 wt.-% polyester. Citregen's polymer component is a citrate-based network of completely amorphous polymer chains crosslinked together to form an elastomeric material. As water penetrates the subject device, surface erosion of the polymer phase occurs through hydrolysis of the ester bonds located between the monomers and at the crosslink sites.
5
F. Comparison of Technological Characteristics
The Citregen TIS and Citrelock have the same intended and indications for use, as well as similar technological characteristics and principles of operation as the predicate device. The minor technological differences between the subject Citregen and predicate Arthrex devices do not raise new issues of safety or effectiveness. The data demonstrates that the Citregen TIS is substantially equivalent to the predicate device.
The subject Acuitive and predicate Arthrex soft tissue fixation devices have similar technological characteristics, including polyester-bioceramic composite materials, thread design, reusable instruments, and standard surgical techniques. The subject device is comprised of Citregen biomaterial, which is a homogeneous biocomposite comprised of unsintered hydroxyapatite (HA) and polyester that is bioresorbed over time in vivo. The predicate Arthrex device is comprised of BioComposite material that is comprised of biphasic calcium phosphate and PLDLA that also resorbs in vivo. The material differences between the Acuitive device and the predicate are the polyester, bioceramic, and weight percentage of bioceramic. The specific materials used differ from the predicate but do not raise different issues of safety or effectiveness, as confirmed by bench, biocompatibility, and animal testing.
The design options and sizes of the Citregen TIS and Citrelock facilitate use in a range of anatomical locations including the foot, ankle, knee, elbow shoulder, hand, and wrist, and are identical to that of the predicate device.
G. Performance Data
The performance characteristics of the Citregen TIS and Citrelock were established via comprehensive studies of packaging, shelf life testing, physical and chemical properties per ASTM F2902, biocompatibility tests per ISO 10993, lifecycle evaluation in GLP rabbit studies, functional performance in vitro, and functional performance in a GLP ovine model of ACL fixation. Biocompatibility evaluation included analysis of extractables and leachables data, in accordance with ISO 10993-18, as the basis for individual Toxicological Risk Assessments at three points along the implant degradation lifecycle, 0, ~25% and ~87%, in lieu of longer term in-vivo data to that same extent of degradation.
Packaging and shelf life tests using real- and accelerated time aging were performed with passing results. Bacterial endotoxin testing showed the Citregen TIS to meet the set endotoxin limits. The biocompatibility of Citregen devices was demonstrated by full panel ISO 10993 testing for a permanent implant and toxicological risk assessment, which includes the long clinical history of unsintered HA and the innate presence of citrate in bone. Biocompatibility studies performed with Citregen devices at various stages of polymer hydrolysis in a GLP rabbit bone implantation model demonstrated biocompatibility with no chronic inflammation at 4, 13, and 26 weeks per ISO 10993-6. E&L testing at various stages of polymer hydrolysis was also performed.
The Citregen TIS and Arthrex predicate devices were evaluated in a GLP functional ovine model of ACL reconstruction for 0, 3-, 6-, and 12-month time points, per ISO 10993-6.
6
The performance characteristics of subject and predicate devices were evaluated using imaging, histological, histomorphometry, and biomechanical data. The results of the study through 12 months demonstrated that the Citregen TIS performance was substantially equivalently to the predicate device.
The Citregen TIS and Arthrex predicate devices were further evaluated in a GLP functional ovine model of ACL reconstruction for 24-months, via imaging studies and inlife assessment.
The results of in vitro E&L analysis, toxicological risk assessment and the histology, histomorphometry, and imaging studies through 24 months in vivo demonstrated that the Citregen TIS and Citrelock performance was substantially equivalently to the predicate device.
H. Conclusion
Based on the indications for use, technological characteristics, and the summary of data submitted, Acuitive Technologies, Inc. has determined that the proposed subject device is substantially equivalent to the currently marketed Arthrex predicate device. Performance testing, including in vivo data and comprehensive assessment of biocompatibility, demonstrated that the device functions as intended without raising new questions of safety or effectiveness.