(267 days)
No
The description focuses on mechanical components and surgical technique, with no mention of AI/ML terms or functionalities.
Yes
The device is intended to treat a meniscus tear by suturing it, directly addressing a health condition.
No
The device is described as an "all-inside meniscal repair device" intended to "suture the meniscus tear", indicating a therapeutic or reparative function, not a diagnostic one.
No
The device description clearly outlines physical components (peek anchors, suture, needle delivery system) and bench testing related to these physical components (biocompatibility, mechanical testing), indicating 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 "suture the meniscus tear to facilitate percutaneous or endoscopic soft tissue procedures." This describes a surgical procedure performed directly on the patient's tissue.
- Device Description: The device is a surgical implant and delivery system designed to physically repair a torn meniscus within the body.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on samples.
The device is clearly a surgical device intended for direct intervention on the patient's anatomy.
N/A
Intended Use / Indications for Use
The Fixone Meniscal Repair is intended to suture the meniscus tear to facilitate percutaneous or endoscopic soft tissue procedures.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Fixone Meniscal Repair are all-inside meniscal repair devices.
Each device includes two peek anchors, pre-tied with non-absorbable suture pre-loaded into a needle delivery system with an adjustable length depth limiter.
The device is made to insert into the joint, place and fix the first anchor(T1) around the ruptured meniscus cartilage, and then place and fix the second anchor(T2) to make one Stitch to seal the torn cartilage.
The device is provided sterile for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
meniscus
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 testing included biocompatibility, mechanical testing including EO residues. The tests demonstrated that the device performs in a substantially equivalent manner to the prior related devices. The following bench testing is performed to demonstrate the functionality is substantially equivalent.
Biocompatibility of the anchor and suture were leveraged from K203523 and K230892, respectively. Biocompatibility of the other portions of the device were evaluated per ISO 10993-1.
Performance tests conducted:
- Extraction test (Property, pH, Potassium permanganate reducing substances, Residue after evaporation, UV spectrum (250 nm ~ 350 nm), Heavy metals, Extractable color (Suture))
- EO residual
- Sterility test (ISO 10993-7, Ethylene oxide Sterilization residuals)
- Comparison test (Pull-out - Fixone Meniscal Repair and FAST-FIX Meniscal Repair System; Fatigue test - FAST-FIX Meniscal Repair System)
- Shelf life testing (Real-time equivalent (RTE) and Accelerated aging temperature, Taa as per AAMI TIR17 and ASTM F 1980-02; Aging temperature: 55±2°C, aging time: 225 days)
- Comparison test (Benchtop performance testing simulating clinical usage)
- External surface
- Length (suture length not less than 95.0% of 750mm)
- Diameter (According to MFDS Notification No.2020-20, "Nonabsorbable Surgical Suture, 4. Diameter")
- Needle attachment (According to MFDS notification No.2020-97, "Surgical suture, non-absorbable, with/without needle")
- Tensile strength (Knot) (According to MFDS notification No.2020-97, "Surgical suture, non-absorbable, with/without needle")
- EO residual (ISO 10993-7, Ethylene oxide Sterilization residuals)
- pH (difference should be 1.5 and less)
- Potassium permanganate reducing substances (difference of consumption should be 2.0 mL and less)
- Residue after evaporation (weight of residue should be 1.0mg and less)
- Heavy metals (no brown color produced within 10 minutes in the tube containing the extract of the prepared sample exceeds that in the tube containing the standard lead solution)
- UV spectrum (250nm~350nm) (Maximum absorbance between 250 to 350 nm should be 0.1 and less)
- Property (test solution should be clear and have no foreign particles)
Endotoxin Test (USP 42 , Bacterial endotoxin test (LAL); USP 42 : 2019, Pyrogen test) will be conducted for each batch of product before shipment. Batches that do not pass will be discarded.
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.
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
Image /page/0/Picture/0 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 the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 2, 2024
Aju Pharm Co., Ltd. % Peter Chung President Plus Global 300, Atwood Street Pittsburgh, Pennsylvania 15213
Re: K233601
Trade/Device Name: Fixone Meniscal Repair Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: June 18, 2024 Received: June 18, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combinationproducts/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-reportmedical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/trainingeducation/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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Christopher Ferreira -S
Christopher Ferreira, M.S. 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
2
Indications for Use
Submission Number (if known)
Device Name
Fixone Meniscal Repair
Indications for Use (Describe)
The Fixone Meniscal Repair is intended to suture the meniscus tear to facilitate percutaneous or endoscopic soft tissue procedures.
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
1. Applicant
- Company : AJU Pharm Co.,Ltd. 1)
-
- Address : A-207, 697, Pangyo-ro, Seongnam-si, Gyeonggi-do, Korea
- Tel : 82-31-765-4420 3)
-
- Fax : 82-31-602-7818
- ട) Prepared date : July 26, 2024
-
- Contact person : Peter Chung, 412-512-8802
- Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA 7)
- Submission type : Traditional 8)
2. Device Information
- Trade name : Fixone Meniscal Repair 1)
- Common name : Fastener, Fixation, Nondegradable, Soft tissue 2)
- Regulation name : Smooth or threaded metallic bone fixation fastener 3)
-
- Product code : MBI
- Regulation number : 888.3040 ട്)
-
- Class of device : Class II
- Panel : Orthopedic 7)
3. The legally marketed device to which we are claiming equivalence
Primary Predicate
K153667, DePuy Synthes/ TRUESPAN Meniscal Repair System (Product Code: MBI)
Additional Predicate K121861, Smith & Nephew Inc. / FAST-FIX Meniscal Repair System (Product Code: GAT)
Reference Device K203523, Aju Pharm Co., Ltd / Fixone Hybrid Knotless Anchor (Product Code: MAI) K230892, Aju Pharm Co., Ltd / Fixone Biocomposite Anchor (Product Code: MAI)
4. Device Description
The Fixone Meniscal Repair are all-inside meniscal repair devices.
Each device includes two peek anchors, pre-tied with non-absorbable suture pre-loaded into a needle delivery system with an adjustable length depth limiter.
The device is made to insert into the joint, place and fix the first anchor(T1) around the ruptured meniscus cartilage, and then place and fix the second anchor(T2) to make one Stitch to seal the torn cartilage.
The device is provided sterile for single use only.
5. Intended Use/Indications for Use
The Fixone Meniscal Repair is intended to suture the meniscus tear to facilitate percutaneous or endoscopic soft tissue procedures.
6. Indications for Use Comparison
The indications for use of the Fixone Meniscal Repair are a subset of the predicate device.
7. Technological Characteristics Comparison
The subject device and predicate device both contain PEEK anchors for meniscal repair. The specific design of the anchors, inserter, and suture are different than the predicate.
8. Performance data:
Bench testing included biocompatibility, mechanical testing including EO residues. The tests
4
demonstrated that the device performs in a substantially equivalent manner to the prior related devices. The following bench testing is performed to demonstrate the functionality is substantially equivalent.
Biocompatibility of the anchor and suture were leveraged from K203523 and K230892, respectively. Biocompatibility of the other portions of the device were evaluated per ISO 10993-1.
| Test item | Requirements | REP NO | |
|---|---|---|---|
| Property | When observing it with the naked eye, test | ||
| solution should be clear and have no foreign | |||
| particles. | MD2019-00537 | ||
| pH | The difference should be 1.5 and less. | ||
| Extraction | |||
| test | 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. | |||
| UV | |||
| spectrum(250 | |||
| nm~350nm) | Maximum absorbance between 250 to 350 nm | ||
| should be 0.1 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 | |||
| Extractable | |||
| color(Suture) | MFDS guideline 2021-3 10.non-absorbable suture | ||
| EO residual | |||
| Sterility test | ISO 10993-7, Ethylene oxide Sterilization residuals | MD2019-00273 | |
| Comparison | |||
| test | Pull-out | 1.Fixone Meniscal Repair | AJU-MD20230728- |
| 01 | |||
| Fatigue test | 2.FAST-FIX Meniscal Repair System | AJU-MD20230728- | |
| 01 | |||
| Shelf life testing | Real-time equivalent (RTE) and Accelerated aging temperature, Taa as per AAMI | ||
| TIR17 and ASTM F 1980-02. | AJ-SLR1902(RO) | ||
| Aging temperature: 55±2°C, aging time: 225 days | AJ-SLR1902(RO) | ||
| Comparison test | Benchtop performance testing simulating clinical usage | AJU-MD20240613- | |
| 01(R1) |
| Test item | Requirements |
|---|---|
| External surface | The test article shall be no damage to the appearance in visual inspection. |
| Length | The length of suture was measured while the strand is laid out smooth, without tension, on a plane surface; the length of the strand is not less than 95.0% of 750mm. |
| Diameter | According to the Technical document (MFDS Notification No.2020-20, "Nonabsorbable Surgical Suture, 4. Diameter") with |
| Needle attachment | Under the conditions of "Surgical suture, non-absorbable, with/without needle" in notification No.2020-97 of MFDS, the test articles should meet the test requirements. |
| Tensile strength (Knot) | Under the conditions of "Surgical suture, non-absorbable, with/without needle" in notification No.2020-97 of MFDS, the test articles should meet the test requirements. |
| EO residual | ISO 10993-7, Ethylene oxide Sterilization residuals |
| pH | The difference should be 1.5 and less. |
| Potassium permanganate | The difference of the consumption of potassium permanganate should |
5
| reducing substances | 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 | |
| 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 foreign particles. |
Endotoxin Test
| # | Test item | Test method / Test criteria |
|---|---|---|
| 1 | Endotoxin test | USP 42 , Bacterial endotoxin test (LAL) |
| 2 | Pyrogen test | USP 42 : 2019, Pyrogen test |
Endotoxin test will be conducted for each batch of product before shipment. The test will be carried out using the Limulus Amebocyte Lysate (LAL) method, recognized by the FDA and internationally. Batches that do not pass the Endotoxin Test will be entirely discarded lots will be documented separately for management purposes. This document will be part of our produce management and quality assurance procedures.
9. Conclusion
The substantial equivalence of the Fixone Meniscal Repair is based on similarities between the intended use, the specifications, and the non-clinical performance testing of the device compared to the legally marketed predicate device. Therefore, it is concluded that Fixone Meniscal Repair is substantially equivalent to the legally marketed predicate device.