(118 days)
INDICATIONS
The SIGMA High Performance Partial Knee System is indicated for single compartmental knee replacement in skeletally mature individuals with osteoarthritis, post-traumatic arthritis of the tibiofemoral surfaces or a history of gout or pseudogout. All components are intended for CEMENTED USE ONLY.
The DePuy SIGMA® High Performance Partial Knee System is a single compartmental knee prosthesis, composed of individually packaged femoral and tibial components designed to be used in various combinations to replace the natural articular surfaces of the knee joint.
The unicompartmental femoral components are Co-Cr-Mo metal implants, available with or without a porous coating. The metal backed tibial components are Co-Cr-Mo and polyethylene and are available without a porous coating. The all-polyethylene unicompartmental tibial component manufactured from polyethylene.
The unicompartmental femoral components are designed for individuals who require a higher than normal degree of flexion (up to 155°).
The provided text describes a 510(k) premarket notification for a medical device, the SIGMA High Performance (HP) Partial Knee System. While the document outlines information about the device itself and its equivalence to predicate devices, it does not contain the acceptance criteria or a study that specifically proves the device meets those criteria in the context of an AI/ML-driven device's performance.
The document states:
- "SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE": This lists a number of engineering and material tests (Biocompatibility, UHMWPE Material Property Characterization, Range of Motion/Constraint, Contact Area/Stress, Wear Testing, Pull-Off, Bacterial Endotoxin testing).
- "SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION - Clinical testing was not necessary to demonstrate substantial equivalence."
This indicates that the submission is focused on demonstrating substantial equivalence based on material properties, design, and manufacturing processes, rather than the performance of an AI/ML algorithm. Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies is not present in the provided text, as these are typically associated with the evaluation of AI/ML software performance.
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April 16, 2020
DePuy Ireland UC % Brad Osborne Regulatory Affairs Specialist II DePuv Synthes. Inc. 700 Orthopaedic Drive Warsaw. Indiana 46582
Re: K193549
Trade/Device Name: SIGMA High Performance (HP) Partial Knee System Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Codes: HRY, OIY Dated: February 17, 2020 Received: February 18, 2020
Dear Brad Osborne:
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
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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,
for Ting Song, Ph.D., R.A.C. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193549
Device Name
SIGMA High Performance (HP) Partial Knee System
Indications for Use (Describe)
INDICATIONS
The SIGMA High Performance Partial Knee System is indicated for single compartment in sketally mature individuals with osteoarthritis, post-traumatic arthritis of the tibiofemoral articular surfaces or a history of gout or pseudogout. All components are intended for CEMENTED USE ONLY.
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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510(K) SUMMARY
(As required by 21 CFR 807.92 and 21 CFR 807.93)
| Submitter Information | |
|---|---|
| Name | DePuy Ireland UC |
| Address | Loughbeg, RingaskiddyCo. Cork Munster, Ireland |
| Phone number | 574-371-4724 |
| Fax number | 574-371-4987 |
| Establishment Registration Number | 1818910 |
| Name of contact person | Brad Osborne |
| Date prepared | 4/16/2020 |
| Name of device | |
| Trade or proprietary name | SIGMA High Performance (HP) Partial Knee System |
| Common or usual name | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer |
| Classification name | Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | Primary: 21 CFR 888.3530Secondary: 21 CFR 888.3560 |
| Product Code(s) | Primary: HRYSecondary: OIY |
| Legally marketed device(s) to whichequivalence is claimed | K070849 DEPUY GCK (SIGMA HP Partial) FEMORAL AND TIBIAL COMPONENTSK070267 DEPUY GCK (SIGMA HP Partial) TIBIAL COMPONENTSK061648 DEPUY GRADUATED COMPARTMENTAL KNEE (GCK) (SIGMA HP Partial)K101433 DEPUY ATTUNE KNEE SYSTEM |
| Reason for 510(k) submission | This submission describes additional inserts compatible with the previously cleared SIGMA HighPerformance (HP) Partial Knee System (previously referred to as DePuy Graduated Compartmental Knee orGCK) and includes a labeling update to the existing IFU. |
| Device description | The DePuy SIGMA® High Performance Partial Knee System is a single compartmental knee prosthesis,composed of individually packaged femoral and tibial components designed to be used in variouscombinations to replace the natural articular surfaces of the knee joint.The unicompartmental femoral components are Co-Cr-Mo metal implants, available with or without aporous coating. The metal backed tibial components are Co-Cr-Mo and polyethylene and are availablewithout a porous coating. The all-polyethylene unicompartmental tibial component manufactured frompolyethylene.The unicompartmental femoral components are designed for individuals who require a higher than normaldegree of flexion (up to 155°). |
| Intended use of the device | The DePuy SIGMA HP Partial Knee System is intended to provide increased patient mobility and reducedpain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient soundbone to seat and support the components. |
| Indications for use | INDICATIONSThe SIGMA High Performance Partial Knee System is indicated for single compartmental kneereplacement in skeletally mature individuals with osteoarthritis, post-traumatic arthritis of thetibiofemoral surfaces or a history of gout or pseudogout. All components are intended forCEMENTED USE ONLY. |
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| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE | |||
|---|---|---|---|
| Characteristics | Subject Device: | Predicate Device: | AOX Reference Device: |
| SIGMA HP Uni AOX Insert | SIGMA HP Partial Knee XLK Insert(K061648, K070267, K070849) | DePuy ATTUNE Knee System AOX Insert(K101433) | |
| Intended Use | Unicondylar Knee Arthroplasty | Unicondylar or Partial Knee Arthroplasty | Total Knee Arthroplasty |
| Properties | |||
| Material | AOX UHMWPE | XLK UHMWPE | AOX UHMWPE |
| Fixation | Cemented | Cemented | Cemented |
| Sizes | Tibial Inserts: 6 Sizes, 7mm-11mm thickness in 1mm increments | Femoral & Tibial Components: 6 SizesTibial Inserts: 6 Sizes, 7mm-11mm thickness in 1mm increments | CR Fixed Bearing Tibial InsertsSizes 1-10 with 5, 6, 7, 8, 10, 12,14, 16mm options for eachPS Fixed Bearing Tibial InsertsSizes 1-10 with 5, 6, 7, 8, 10, 12,14, 16 mm options for each |
| Modularity | Metal femoral component andeither an all polyethylene tibialcomponent or metal tibialcomponent with polyethyleneinsert | Metal femoral component and either anall polyethylene tibial component ormetal tibial component with polyethyleneinsert | N/A |
| Packaging Description | |||
| Component | Inner foil pouch laminated outof foil/LLDPE/Polyestermaterials and vacuumed,packaged inside a Tyvek/blistertray with a foam protector | Double PETG Blister/Tyvek | Inner foil pouchesand outer rigidblister trays with Tyvek lids |
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| Sterility | |||
|---|---|---|---|
| Sterile Method | Gamma Irradiation | Gas Plasma Sterilization | Gamma Irradiation |
| Sterility Assurance Level | $10^{-6}$ | $10^{-6}$ | $10^{-6}$ |
| Shelf Life | 5 Years | 5 Years | 5 Years |
| Purpose of Submission | |||
| This submission adds an AOX material option to the existing legally marketed SIGMA High Performance (HP) Partial Knee System (K070267, | |||
| K070849, K061648). The SIGMA HP Partial AOX insert is equivalent to the primary predicate SIGMA HP Partial XLK Insert (K070267) in intended | |||
| use, geometry, design, fixation, and compatibility. The AOX material is similar to the AOX UHMWPE material used in the manufacture of the legally | |||
| marketed ATTUNE® Primary Knee System. All three poly materials conform to ASTM-F648. This submission also includes a labeling update to the | |||
| existing SIGMA HP Partial Knee System IFU. |
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PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The following tests were performed (per FDA's Class II Special Controls Guidance Document: Knee Joint Patellofenerotibial Metal/Polyner Porous-Coated Uncenented Prosheses; Guidance for Industry and FDA) on the SIGMA High Performance (HP) Patial Knee AOX Insert to demonstrate substantial equivalence of safety and efficacy with the predicate device:
- Biocompatibility .
- UHMWPE Material Property Characterization .
- Range of Motion/Constraint ●
- Contact Area/Stress ●
- Wear Testing ●
- Pull-Off .
The proposed devices also meet the requirement of bacterial endotoxin testing as specified in ANSI AAMI ST-72:2011.
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
Clinical testing was not necessary to demonstrate substantial equivalence.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The subject DePuy SIGMA High Performance Partial Kneets are substantially equivalent to the predicate SIGMA High Performance Partial Knee System.
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.