(60 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies focus on material properties and mechanical performance, not algorithmic analysis.
Yes.
The device is clearly indicated for the treatment of various pathological conditions affecting the knee and hip joints, such as osteoarthritis, rheumatoid arthritis, and traumatic arthritis, which aligns with the definition of a therapeutic device designed to treat or alleviate disease.
No.
The device descriptions and intended uses provided are for E1™ Tibial Bearings and E1™ Acetabular Liners, which are prosthetic components for joint replacement (knee and hip). Their purpose is to treat pain, functional deformities, and failures of previous procedures, not to diagnose conditions.
No
The device description and intended use clearly indicate that the devices are physical implants (tibial bearings and acetabular liners) used in knee and hip replacement surgeries. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used to replace or correct problems within the knee and hip joints due to various conditions. This is a surgical implant, not a test performed on a sample taken from the body.
- Device Description: The description refers to "Tibial Bearings" and "Acetabular Liners," which are components of joint replacement implants.
- Anatomical Site: The anatomical sites are the knee and hip joints, which are internal body parts where the device is implanted.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a therapeutic device used to physically replace or repair damaged joints.
N/A
Intended Use / Indications for Use
E1™ Tibial Bearings:
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
- Correction of varus, valgus, or posttraumatic deformity.
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
For cemented and un-cemented use.
E1™ Acetabular Liners:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis.
- Correction of functional deformity.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- Revision of previously failed total hip arthroplasty.
Cemented and Uncemented Applications (as based on mating shell)
Product codes (comma separated list FDA assigned to the subject device)
OIY, OQG, OQH, OQI, JWH, JDI, LZO, MAY, LPH, LWJ
Device Description
The device descriptions of the E1™ Tibial Bearings and the E1 ™ Acetabular Liners have not changed from the original predicate submissions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint, Hip
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)
Non-Clinical Testing: Further testing showed no decreases in the mechanical properties after accelerated aging. In contrast to the control materials, the E1™ hip and the E1™ knee materials showed no evidence of oxidation or oxidative degradation.
Clinical Testing: None provided
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.
K080528, K070364, K070399, K073102, K090103
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
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
K10004B
MAR - 9 2010
510(k) Summary
March 3, 2010 Date:
Biomet Manufacturing Corp. Applicant/Sponsor:
Contact Person: Becky Earl Regulatory Specialist
E1™ Antioxidant Infused Technology Proprietary Name: (E1™ previously known as E-Poly™)
Common or Usual Name: UHMWPE with antioxidant
Classification Name:
- OIY-knee joint patellofemorotibial polymer/metal/polymer semi-. constrained cemented prosthesis (888.3560)
- OQG-prosthesis, hip, semi-constrained, metal/polymer + additive, porous . uncemented (888.3358)
- OQH-prosthesis, hip, semi-constrained, metal/polymer + additive, . cemented (888.3350)
- OQI-prosthesis, hip, semi-constrained, metal/ceramic/polymer + additive, ● cemented or porous uncemented (888.3353)
- JWH -cemented semi-constrained polymer/metal/polymer knee prosthesis . (888.3560)
- LPH-prosthesis, hip, semi-constrained, metal/polymer, . Porous uncemented (888.3358);
- JDI-prosthesis, hip, semi-constrained, metal/polymer, . Cemented (888.3350);
- LWJ-prosthesis, hip, semi-constrained, metal/polymer, . Uncemented (888.3360);
- MAY-prosthesis, hip, semi-constrained, metal/ceramic/ . Polymer, cemented or non-porous cemented, osteophilic finish (888.3353);
- LZO-prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented . or non-porous, uncemented (888.3353)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: The predicate devices are the E-Poly™ Tibial Bearings, K080528, cleared June 17, 2008; E-Poly™ MaxRom™ Acetabular Liners, K070364, cleared May 3, 2007;
1
510(k) Summary E1™ Antioxidant Infused Technology Biomet Manufacturing Corp. Page 2
E-Poly™ (100kGy) Acetabular Liners-Additional Profiles, K070399, cleared May 4, 2007; Biolox® delta Ceramic Heads with 100 kGy E-Poly™ Acetabular Liners, K073102, cleared November 27, 2007; and 100kGy Acetabular Liners Additional Profiles: +3 MaxRom™ and +3 Hi-Wall, K090103, cleared February 11, 2009.
Device Description: The device descriptions of the E1™ Tibial Bearings and the E1 ™ Acetabular Liners have not changed from the original predicate submissions.
Indications For Use:
E1™ Tibial Bearings
-
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
-
- Correction of varus, valgus, or posttraumatic deformity.
-
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
E1™ Acetabular Liners
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Correction of functional deformity.
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
-
- Revision of previously failed total hip arthroplasty.
Cemented and Uncemented Applications.
Summary of Technologies: The E1™Antioxidant Infused Technology is identical to that of the predicate devices.
Non-Clinical Testing: Further testing showed no decreases in the mechanical properties after accelerated aging. In contrast to the control materials, the E1™ hip and the E1™ knee materials showed no evidence of oxidation or oxidative degradation.
Clinical Testing: None provided
p. 2 of 2
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. The stylized symbol on the right features three abstract human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
BioMet Manufacturing Corp. % Ms. Becky Earl Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K100048
Trade/Device Name: E1™ Tibial Bearings and E1TM Acetabular Liners Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: OIY, OQG, OQH, OQI, JWH, JDI, LZO, MAY, LPH, LWJ Dated: January 7, 2010 Received: January 8, 2010
MAR - 9 2010
Dear Ms. Earl:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Becky Earl
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Clavbare Buehm
Mark N. Mel Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
100048 510(k) Number (if known):
Device Name: E1™ Acetabular Liners
Indications for Use:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Correction of functional deformity.
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
-
- Revision of previously failed total hip arthroplasty.
Cemented and Uncemented Applications (as based on mating shell)
Prescription Use _ YES (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Soutu
(Division Sign-Off)
for mxn
Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number K100048
5
Indications for Use
100048 510(k) Number (if known):
E1™ Tibial Bearings Device Name:
.
Indications for Use:
-
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
-
- Correction of varus, valqus, or posttraumatic deformity.
-
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
For cemented and un-cemented use.
YES Prescription Use_ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qnita for mxn
(Division Signal Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100048