(445 days)
Not Found
No
The document describes a mechanical suture anchor and its intended use, with no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
The device is intended to reattach soft tissue to bone and stabilize damaged soft tissue, which are therapeutic actions.
No
The device is a non-absorbable suture anchor used in orthopedic surgical procedures to reattach soft tissue to bone. Its function is interventional/reparative, not diagnostic.
No
The device description clearly states it is a physical suture anchor made of UHMWPE and PET fibers, pre-loaded on a handled insertion device. It is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "reattach soft tissue to bone in orthopedic surgical procedures." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "suture anchor" made of sutures and an insertion device, designed for implantation into bone.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical implant used to repair anatomical structures.
N/A
Intended Use / Indications for Use
The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The Fixone All Suture Anchors may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, they may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In conjunction with appropriate postoperative immobilization throughout the suture anchor systems stabilize the damaged soft tissue.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
Fixone All suture anchor consists of one "fix Suture" and two or three non-absorbable Sutures. The nonabsorbable suture is manufactured from UHMWPE and PET fibers. Fixone All suture anchor is implanted using its self-punching option. They are pre-loaded on a handled insertion device is provided sterile, for single use only. This device is medical device. Prescription use only.
This device is could used with instrument that manufactured by Aju Pharm Co.,Ltd. It is consist of 4 models. It provide non-sterile (user must sterilization before use).
| Product name | Instrument / 4 model codes including Fixone.I.B-Awl450a |
|---|---|
| Model name | Fixone.I.B-Awl450a, Fixone.I.B-Awl550a, Fixone.I.B-Awl450ak, Fixone.I.B-Awl550a |
| Intended use | The instrument for making a hole in the bone |
| Manufacturer | Ajupharm / Korea |
| Sterilization | Non-sterile |
| Sterilization method | Autoclave / 132°C / 4min / 20 min dry |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopedic surgical procedures
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench tests were performed, including biocompatibility and 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 was performed to demonstrate functionality is substantially equivalent:
- Surface: When examined by normal vision, the surface shall be free from defects. Result: Pass.
- Nominal size (Exclude suture): When tested by Vernier calipers, micrometer or tapeline, the measurement should be in accordance with standard. Result: MD201 8-00210.
- Sterilization: ISO 11135:2014 - Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices. Result: ME-SVP-1802.
- Shelf Life and Packaging: ISO11607-2 / EN 868-5 / ASTM F1980-16 / ASTM F88-15 / ASTM F1929:1998. Result: AJ-SL1702.
- Comparison test with predicate device (Insertion test): 10pcf/40pfc Polyurethane block, self-punching / Implantation angle of 90 (vertical). Result: AJU_M.
- Comparison test with predicate device (Pull-out test): 10pcf/40pfc Polyurethane block, self-punching / Pull-out angle of 90 (vertical) with MTS Bionix servohydraulic tester. Result: D20201006_PT(Js, Yknot).
- Comparison test with predicate device (Fatigue test): 10pcf/40pfc Polyurethane block, self-punching / with same cycle loading and rate. Result: Yknot.
- Comparison testing process was based on the test of predicate device. See attached 'Biochemical Comparison_All Suture Anchor' / 'Fixation Strength Biochemical Data'.
Biocompatibility tests performed:
- Cytotoxicity: ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity. Result: Pass.
- Systemic toxicity test: ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity. Result: Pass.
- Pyrogen Test: ISO 10993-11 Test for systemic toxicity, pyrogen test. Result: Pass.
- Intracutaneous reactivity test: ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. Result: Pass.
- Maximization sensitization: ISO 10993-10, Test for irritation and skin sensitization, Maximization test for delayed hypersensitivity. Result: Pass.
- Genotoxicity test: ISO 10993-3, Genotoxicity test OECE 471, Bacterial reverse mutation test. Result: Pass.
- Implantation test: ISO 10993-6, Tests for local effects after implantation, Annex D test methods for implantation in bone. Result: Pass.
- Hemolysis test: ISO 10993-4, Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood. Result: Pass.
- Subchronic toxicity: ISO 10993-11 Tests for systemic toxicity. Result: Pass.
Key results: The performance tests demonstrated that Fixone All Suture Anchor performs in a substantially equivalent manner to the predicate device.
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
§ 888.3040 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
December 15, 2020
Image /page/0/Picture/1 description: The image shows 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 a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
AJU Pharm Co., Ltd. % Peter Chung President Plus Global 300 Atwood Street Pittsburgh, Pennsylvania 15213
Re: K192709
Trade/Device Name: Fixone All 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 20, 2019 Received: September 27, 2019
Dear Peter 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
1
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 (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 medical devices and radiation-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 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
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K192709
Device Name Fixone All Suture Anchor
Indications for Use (Describe)
The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The Fixone All Suture Anchors may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, they may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In conjunction with appropriate postoperative immobilization throughout the suture anchor systems stabilize the damaged soft tissue.
| 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
[as required by 807.92(c)]
1. Applicant
- Company : AJU Pharm Co.,Ltd. 1)
-
- Address : A-207, 697, Pangyo-ro, Seongnam-si, Gyeonggi-do, Korea
-
- Tel : 82-31-765-4420
-
- Fax : 82-31-602-7818
- Prepared date : Sep. 01, 2019 5)
- ୧) Contact person : Peter Chung, 412-512-8802
-
- Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA
-
- Submission date : Mar.11, 2020
2. Device Information
-
- Trade name : Fixone All Suture Anchor
-
- Common name : Non-absorbable Suture Anchor
-
- Regulation name : Fastener, Fixation, Nondegradable, Soft tissue
-
- Product code : MBI
-
- Regulation number : 888.3040
- ୧) Class of device : Class II
-
- Panel : Orthopedic
3. The legally marketed device to which we are claiming equivalence
K133224, ConMed Corporation / Y-Knot RC All-Suture Anchor w/Two and Three #2
4. Device description
Fixone All suture anchor consists of one "fix Suture" and two or three non-absorbable Sutures. The nonabsorbable suture is manufactured from UHMWPE and PET fibers. Fixone All suture anchor is implanted using its self-punching option. They are pre-loaded on a handled insertion device is provided sterile, for single use only. This device is medical device. Prescription use only.
This device is could used with instrument that manufactured by Aju Pharm Co.,Ltd. It is consist of 4 models. It provide non-sterile (user must sterilization before use).
| Product name | Instrument / 4 model codes including Fixone.I.B-Awl450a |
|---|---|
| Model name | Fixone.I.B-Awl450a, Fixone.I.B-Awl550a, Fixone.I.B-Awl450ak, Fixone.I.B-Awl550a |
| Intended use | The instrument for making a hole in the bone |
| Manufacturer | Ajupharm / Korea |
| Sterilization | Non-sterile |
| Sterilization method | Autoclave / 132°C / 4min / 20 min dry |
5. Intended Use :
The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The Fixone All Suture Anchors may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, they may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In conjunction with appropriate postoperative immobilization throughout the healing period, the suture anchor systems stabilize the damaged soft tissue.
4
6. Performance data:
- Bench test were performed. Bench testing included biocompatibility, mechanical testing 1) 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 | |
|---|---|---|---|
| Surface | When examined by normal vision, the surface shall be free from defects. | Pass | |
| Nominal size (Exclude suture) | When tested by Vernier calipers, micrometer or tapeline, the measurement should be in accordance with standard. | MD201 | |
| 8-00210 | |||
| Sterilization | ISO 11135:2014-Sterilization of health care products - Ethylene oxide - | ||
| Requirements for development, validation and routine control of a | |||
| sterilization process for medical devices | ME- | ||
| SVP- | |||
| 1802 | |||
| Shelf Life and Packaging | ISO11607-2 / EN 868-5 / ASTM F1980-16 / ASTM F88-15 / ASTM | ||
| F1929:1998 | AJ- | ||
| SL1702 | |||
| Comparison test with | |||
| predicate device | Insertion test | 10pcf/40pfc Polyurethane block, self-punching / | |
| Implantation angle of 90 (vertical) | AJU_M | ||
| Pull-out test | 10pcf/40pfc Polyurethane block, self-punching / Pull- | ||
| out angle of 90 (vertical) with MTS Bionix | |||
| servohydraulic tester | D20201 | ||
| 006_PT( | |||
| Js, | |||
| Fatigue test | 10pcf/40pfc Polyurethane block, self-punching / with | ||
| same cycle loading and rate | Yknot) |
1-1) Comparison testing process was based on the test of predicate device. See attached 'Biochemical Comparison_All Suture Anchor' / 'Fixation Strength Biochemical Data'.
-
- Biocompatibility
| # | 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 |
| 7 | Implantation test | ISO 10993-6, Tests for local effects after implantation, Annex D test methods for implantation in bone | Pass |
| 8 | Hemolysis test | ISO 10993-4, Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood | Pass |
| 9 | Subchronic toxicity | ISO 10993-11 Tests for systemic toxicity | Pass |
The performance tests demonstrated that Fixone All Suture Anchor performs in a substantially equivalent manner to the predicate device.
5
7. Predicate device comparison table
| Manufacturer | ConMed Corporation | AJU Pharm Co.,Ltd. | Remark |
|---|---|---|---|
| 510(k) No. | K133224 | N/A | |
| Indication for | |||
| use | The non-absorbable suture anchors are | ||
| intended to reattach soft tissue to bone in | |||
| orthopedic surgical procedures. The Fixone | |||
| All Suture Anchors may be used in either | |||
| arthroscopic or open surgical procedures. | |||
| After the suture strands are anchored to the | |||
| bone, they may be used to reattach soft | |||
| tissue, such as ligaments, tendons, or joint | |||
| capsules to the bone. In conjunction with | |||
| appropriate postoperative immobilization | |||
| throughout the healing period, the suture | |||
| anchor systems stabilize the damaged soft | |||
| tissue. | The non-absorbable suture anchors are | ||
| intended to reattach soft tissue to bone in | |||
| orthopedic surgical procedures. The Fixone | |||
| All Suture Anchors may be used in either | |||
| arthroscopic or open surgical procedures. | |||
| After the suture strands are anchored to the | |||
| bone, they may be used to reattach soft | |||
| tissue, such as ligaments, tendons, or joint | |||
| capsules to the bone. In conjunction with | |||
| appropriate postoperative immobilization | |||
| throughout the healing period, the suture | |||
| anchor systems stabilize the damaged soft | |||
| tissue. | Same | ||
| Classification | |||
| name | Fastener, Fixation, Nondegradable, Soft | ||
| Tissue | Fastener, Fixation, Nondegradable, Soft | ||
| Tissue | Same | ||
| Trade name | Y-Knot RC All-suture Anchor | Fixone All Suture Anchor | N/A |
| Model/type | - | 14 model codes including FAJ-1652802ew | N/A |
| Appearance | Image: Y-Knot RC All-suture Anchor | Image: Fixone All Suture Anchor | Similar |
| Product | |||
| configuration | Driver | ||
| Suture Anchor | Driver | ||
| Suture Anchor | Same | ||
| Material | Non-absorbable Suture | Non-absorbable Suture | Same |
| 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 | Non-absorbable Suture | Non-absorbable Suture | Same |
| Sterilization | EO Gas sterilization | ||
| According to ISO 11135: 2014 | EO Gas sterilization | ||
| According to ISO 11135: 2014 | Same | ||
| Biodegradable | Yes | Yes | Same |
| Principle of | |||
| operation | Manual (Self punching) | Manual (Self punching) | Same |
| Shelf-life | 5 years | 5 years | Same |
| Performance | |||
| testing | Pull-out | ||
| Insertion | |||
| Fatigue | Pull-out | ||
| Insertion | |||
| Fatigue | Same |
8. Conclusion
The device is investigated for function to compare the operation of function between Fixone All Suture 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 All Suture Anchor is substantially equivalent to the legally marketed predicate device.