(183 days)
Not Found
No
The document describes a physical implantable device (biocomposite anchor) and its intended use for tissue fixation. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML.
Yes
The device is used to fix soft tissue to bone for repair procedures in various parts of the body, which directly constitutes a therapeutic intervention.
No
The device is an anchor used for reattaching soft tissue to bone during surgical procedures, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states the device is a physical anchor manufactured from biodegradable materials and a nonresorbable suture, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states 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 description details a physical implantable device made of biodegradable materials and suture.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is an implantable surgical device used inside the body for structural support.
N/A
Intended Use / Indications for Use
The Fixone Biocomposite Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. Capsular Shift or Capsulolabral Reconstruction:
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair. Posterior Oblique Ligament Repair. Iliotibial Band Tenodesis:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
MAI
Device Description
The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The anchor is manufactured from biodegradable materials (PLGA copolymer and beta-TCP). A nonresorbable suture manufactured from cobraided UHMWPE and PET fibers is inserted into the anchor is implanted using a provided driver.
This device is could used with instrument that manufactured by Aju Pharm Co.,Ltd. It is consist of 18 models. It provide non-sterile (user must sterilization before use).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot/Ankle, Knee, 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)
Bench test were performed. Bench testing included biocompatibility, mechanical testing including EO residues. The tests demonstrated that the device performs in a substantially equivalent manner to the predicate device. The following bench testing is performed to demonstrate the functionality is substantially equivalent.
Test items included: External surface, Measurement, Insertion torque, Fixation strength, Tensile strength, Extractable color, Extraction test, pH, Potassium permanganate reducing substances, Residue after evaporation, Heavy metals, UV spectrum (250nm~350nm), Property. All results were "Pass".
Performance comparison test of FIXONE and Arthrex suture anchor included: Insertion force, Insertion torque, Pull-out test, Fatigue test. All results were "Pass".
Performance Testing of Fixone Biocomposite Anchor (Pull-out test) by immersion time of saline solution to evaluate two bioabsorbable suture anchors. Absorption time: 5min, 1hr, 4hr, 8hr, 12hr, 24hr; 4 weeks, 6 weeks, 12 weeks and 26 weeks. All results were "Pass".
Shelf life testing was performed by setting Real-time equivalent (RTE) and Accelerated aging temperature, Taa as per AAMI TIR17 and ASTM F 1980-02. Aging temperature: 55 +/- 2 degrees C, aging time: 225 days.
Biocompatibility tests for Anchor included: Cytotoxicity, Acute systemic toxicity test, Pyrogen Test, Intracutaneous (intradermal) reactivity test, Maximization test for delayed hypersensitivity, Bacterial revers mutation test, Mammalian erythrocyte micronucleus test, Implantation test, Bioabsorbable screws test, Subchronic toxicity test. All results were "Pass".
Biocompatibility tests for Suture included: Cytotoxicity, Systemic toxicity test, Pyrogen Test, Intracutaneous reactivity test, Maximization sensitization, Genotoxicity test, Implantation test, Hemolysis test. All results were "Pass".
Final product LAL test: LAL test was performed in final product that consist of anchor and suture. Result: Pass.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
March 11, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
AJU Pharm Co., Ltd. % Peter Chung President Plus Global 300 Atwood Street Pittsburgh, Pennsylvania 15213
Re: K192484
Trade/Device Name: Fixone Biocomposite Anchor 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: February 5, 2020 Received: February 11, 2020
Dear Mr. Chung:
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 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
1
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 (QS) 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.
for
Laura Rose. Ph.D. Acting 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
510(k) Number (if known)
Device Name
Fixone Biocomposite Anchor
Indications for Use (Describe)
The Fixone Biocomposite Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. Capsular Shift or Capsulolabral Reconstruction:
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair. Posterior Oblique Ligament Repair. lliotibial Band Tenodesis:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Type of Use (Select one or both, as applicable)
X 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 [K192484]
1. Applicant
- Company : AJU Pharm Co.,Ltd. 1)
-
- Address : A-207, 697, Pangyo-ro, Seongnam-si, Gyeonggi-do, Korea
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- Tel : 82-31-765-4420
-
- Fax : 82-31-602-7818
- Prepared date : Sep. 01, 2019 5)
-
- Contact person : Peter Chung, 412-512-8802
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- Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA
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- Submission date : Mar. 11, 2020
- ರು) Submission type : Traditional
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- Prior related submissions : K171299
2. Device Information
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- Trade name : Fixone Biocomposite Anchor
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- Common name : Biodegradable Orthopedic Bone Screw
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- Regulation name : Fastener, Screw, Fixation, Bone, Suture
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- Product code : MAI
-
- Regulation number : 888.3030
- Class of device : Class II 6)
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- Panel : Orthopedic
3. The legally marketed device to which we are claiming equivalence
K171299, Aju Pharm Co., Ltd. / Fixone Biocomposite Anchor
4. Device description
The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The anchor is manufactured from biodegradable materials (PLGA copolymer and β-ΤCP). A nonresorbable suture manufactured from cobraided UHMWPE and PET fibers is inserted into the anchor is implanted using a provided driver.
This device is could used with instrument that manufactured by Aju Pharm Co.,Ltd. It is consist of 18 models. It provide non-sterile (user must sterilization before use).
| Product name | Instrument / 20 model codes including Fixone.I.B-A/T450a |
|---|---|
| Intended use | The instrument of make the hole in the bone. |
| Manufacturer | AJU Pharm Co.,Ltd. / Korea |
| Characteristic | This device is provided as Non-sterile and Reusable device. |
| This device is provided non-sterile. This device is user-sterilized. | |
| Sterilization method | Autoclave / 132°C / 4min / 20 min dry |
5. Intended Use :
The Fixone Biocomposite Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures:
Shoulder: Rotator Cuff Repair, 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;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
6. Performance data:
- Bench test were performed. Bench testing included biocompatibility, mechanical testing 1)
4
including EO residues. The tests demonstrated that the device performs in a substantially equivalent manner to the predicate device. The following bench testing is performed to demonstrate the functionality is substantially equivalent.
| Test item | Requirements | Results |
|---|---|---|
| External surface | ||
| Measurement | ASTM F2502 and USP | Pass |
| Insertion torque | ||
| Fixation strength | ||
| Tensile strength | ||
| Extractable color | ||
| Extraction test | ||
| pH | The difference should be 1.5 and less. | |
| Potassium permanganate | ||
| reducing substances | The difference of the consumption of potassium permanganate should | |
| be 2.0 mL and less. | ||
| Residue after evaporation | Record the weight of the residue should be 1.0mg and less. | |
| Heavy metals | Any brown color produced within 10 minutes in the tube containing the | |
| extract of the prepared sample does not exceed that in the tube | ||
| containing the standard lead solution | Pass | |
| UV spectrum(250nm~350nm) | Maximum absorbance between 250 to 350 nm should be 0.1 and less. | |
| Property | When observing it with the naked eye, test solution should be clear and | |
| have no forign particles. | ||
| Performance comparision test of FIXONE and Arthrex suture anchor | ||
| Insertion force | ||
| Insertion torque | ASTM F2502 | |
| Pull-out test | Pass | |
| Fatigue test | The anchor shall be inserted into the pilot hole. | |
| Apply the load 50% of Pull-out test(offset 10%, Sine shape) - 30° (worst | ||
| case) | ||
| Performance Testing of Fixone® Biocomposite Anchor (Pull-out test) | ||
| Pull-out test by immersion time of saline solution to evaluate two bioabsorbable suture anchors. | ||
| [Absorption time (soaking time) : 5min, 1hr, 4hr, 8hr, 12hr, 24hr | ||
| ASTM F1839-08, Standard specification for RGID Polyurethane Foam for Use as a Standard Mate | ||
| rial for Testing Orthopaedic Devices and Instruments | Pass | |
| Performance Testing of Fixone® Biocomposite Anchor (Pull-out test) | ||
| Pull-out test by immersion time of saline solution to evaluate two bioabsorbable suture anchors. | ||
| [Absorption time (soaking time) : 4 weeks, 6 weeks, 12 weeks and 26 weeks | ||
| ASTM F1839-08, Standard specification for RGID Polyurethane Foam for Use as a Standard Material for | ||
| Testing Orthopaedic Devices and Instruments | Pass | |
| Shelf life testing | ||
| To make shelf life time, my company set Real-time equivalent (RTE) and Accelerated aging temperature, | ||
| Taa as per AAMI TIR17 and ASTM F 1980-02. | ||
| Aging temperature: 55±2℃, aging time: 225 days |
2) Biocompatibility
| Anchor | |||
|---|---|---|---|
| # | Test item | Test method / Test criteria | Test result |
| 1 | Cytotoxicity | ISO 10993-5(2009) Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Pass |
| 2 | Acute systemic toxicity test | ISO 10993-11(2009) Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Pass |
| 3 | Pyrogen Test | ISO 10993-11 Test for systemic toxicity, pyrogen test | Pass |
| 4 | Intracutaneous(intradermal) reactivity test | ISO 10993-10(2013) Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Pass |
| 5 | Maximization test for delayed hypersensitivity | ISO 10993-10(2013) Test for irritation and skin sensitization, Maximization test for delayed hypersensitivity | Pass |
5
| 6 | Bacterial revers mutation
test | ISO 10993-3, Genotoxicity test OECE 471, Bacterial reverse
mutation test | Pass |
|----|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|------|
| 7 | Mammalian erythrocyte
micronucleus test | ISO 10993-3, Genotoxicity test OECE 471, Bacterial reverse
mutation test | Pass |
| 8 | Implantation test | ISO 10993-6, Tests for local effects after implantation, Annex D
test methods for implantation in bone | Pass |
| 9 | Bioabsorbable screws test | ASTM F2502 Standard specification and test methods for
bioabsorbable plates and screws for internal fixation implants | Pass |
| 10 | Subchronic toxicity test | ISO 10993-11 Biological Evaluation of Medical Devices Part 11-
Test for systemic toxicity | Pass |
| Suture | |||
|---|---|---|---|
| # | Test item | Test method / Test criteria | Test result |
| 1 | Cytotoxicity | ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in | |
| vitro cytotoxicity | Pass | ||
| 2 | Systemic toxicity test | ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for | |
| systemic toxicity | Pass | ||
| 3 | Pyrogen Test | ISO 10993-11 Test for systemic toxicity, pyrogen test | Pass |
| 4 | Intracutaneous reactivity test | ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for | |
| irritation and skin sensitization | Pass | ||
| 5 | Maximization sensitization | ISO 10993-10, Test for irritation and skin sensitization, Maximization test | |
| for delayed hypersensitivity | Pass | ||
| 6 | Genotoxicity test | ISO 10993-3, Genotoxicity test OECE 471, Bacterial reverse mutation test | Pass |
| 8 | Implantation test | ISO 10993-6, Tests for local effects after implantation, Annex D test | |
| methods for implantation in bone | Pass | ||
| 9 | Hemolysis test | ISO 10993-4, Biological evaluation of medical devices - Part 4: Selection of | |
| tests for interactions with blood | Pass |
Final product
| 1 | LAL test | USP 38 NF 33 Bacterial Endotoxin test "Gel clot method" | Pass |
|---|---|---|---|
| LAL test was performed in final product that consist of anchor and suture. |
The performance tests demonstrated that Fixone Biocomposite Anchor performs in a substantially equivalent manner to the predicate device.
7. Predicate device comparison table
| Manufacturer | AJU Pharm Co.,Ltd. | AJU Pharm Co.,Ltd. | Remark |
|---|---|---|---|
| 510(k) No. | K171299 | N/A | |
| Indication for use | The Fixone Biocomposite Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures: | ||
| Shoulder: Rotator Cuff Repair, 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; | |||
| Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; | |||
| Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. | The Fixone Biocomposite Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures: | ||
| Shoulder: Rotator Cuff Repair, 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; | |||
| Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; | |||
| Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. | Same | ||
| Classification name | Fastener. Screw. Fixation, Bone, Suture | Fastener. Screw. Fixation, Bone, Suture |
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Ajupharm Co., Ltd. / Fixone Biocomposite Anchor / 510(k) Summary / K192484
| Manufacturer | AJU Pharm Co.,Ltd. | AJU Pharm Co.,Ltd. | Remark |
|---|---|---|---|
| Trade name | Fixone Biocomposite Anchor | Fixone Biocomposite Anchor | Same |
| Model/type | 80 model codes including BAB-45001a | 161 model codes including BAB-45001a | N/A |
| Product | |||
| configuration | Driver | Driver | Same |
| Anchor | Anchor | ||
| Suture | Suture | ||
| Material | PLGA(70%) + β-TCP(30%) | PLGA(70%) + β-TCP(30%) | Same |
| Anchor | |||
| Outside diameter | 4.5mm/4.75mm/5.5mm/5.75mm/6.5mm | 3.0mm/4.5mm/4.75mm | |
| 5.5mm/5.75mm/6.5mm | Similar | ||
| Length of abchor | 14.6mm/15mm/15.7mm/16mm/16.8mm | 11.9mm/14.6mm/15mm/15.7mm | |
| 16mm/16.5mm/16.8mm | Similar | ||
| Suture | |||
| Absorbable | Non-absorbable | Non-absorbable | Same |
| Suture diameter | 0.50~0.599 (USP size 2) | 0.50~0.599 (USP size 2) | Same |
| Material | Polyethylene | Polyethylene | Same |
| Sterilization | EO Gas sterilization | EO Gas sterilization | Same |
| According to ISO 11135: 2014 | According to ISO 11135: 2014 | ||
| Biodegradable | Yes | Yes | Same |
| Principle of | |||
| operation | Manual | Manual | Same |
| Shelf-life | 5 years | 5 years | Same |
9. Conclusion
The device is investigated for function to compare the operation of function between Fixone Biocomposite Anchor and predicate devices.
Comparison results demonstrate that the specifications and performance of the device are substantially equivalent to the legally marketed predicate device.
Therefore, it is concluded that Fixone Biocomposite Anchor is substantially equivalent to the legally marketed predicate device.