(57 days)
No
The summary describes a passive implant made of PEEK for spinal fusion and does not mention any computational or analytical capabilities, let alone AI/ML.
No.
The device is an intervertebral body spacer used in fusion procedures to facilitate bone fusion, not to directly treat or alleviate symptoms in a therapeutic manner.
No
The device is an ALIF spacer intended for intervertebral body fusion, which is a treatment, not a diagnostic process.
No
The device description clearly states it is a contoured device constructed of Polyetheretherketone (PEEK), indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The PEEK-OPTIMA® ALIF Spacer is a physical implant designed to be surgically placed in the spine to facilitate bone fusion. It does not perform any tests on bodily samples.
- Intended Use: The intended use clearly describes a surgical procedure for spinal fusion, not a diagnostic test.
The information provided describes a surgical implant, not a diagnostic device.
N/A
Intended Use / Indications for Use
The PEEK-OPTIMA® ALIF Spacer is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The PEEK-OPTIMA® ALIF Spacer is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The PEEK-OPTIMA® ALIF Spacer is a contoured device constructed of Polyetheretherketone (PEEK) medical grade, for spinal applications, inserted into the intervertebral body space of the lumbosacral spine for intervertebral body fusion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine from L2 to S1
Indicated Patient Age Range
skeletally mature
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)
Not Found
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
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
510(K) Summa
AUG - 7 2008
| Preparation Date: | July 30, 2008 |
|---|---|
| Applicant/Sponsor: | Biomet Spine |
| 100 Interpace Parkway | |
| Parsippany, NJ 07054 | |
| Contact Person: | Vivian Kelly |
| Phone: 973-299-9300 x2214 | |
| Fax: 973-257-0232 | |
| Trade name: | PEEK-OPTIMA® ALIF Spacer |
| Common Name: | Intervertebral body fusion device |
| Classification Name: | Intervertebral fusion device, 21 CFR §888.3080 |
| Device Panel /Product Code: | Orthopedic MAX |
Device Description:
The PEEK-OPTIMA® ALIF Spacer is a contoured device constructed of Polyetheretherketone (PEEK) medical grade, for spinal applications, inserted into the intervertebral body space of the lumbosacral spine for intervertebral body fusion.
Indications for Use:
The PEEK-OPTIMA® ALIF Spacer is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The PEEK-OPTIMA® ALIF Spacer is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
Summary of Technologies:
The technological characteristics (material, design and sizing) of the PEEK-OPTIMA® ALIF Spacer are the same as, or similar to, the predicate devices.
Substantial Equivalence:
The PEEK-OPTIMA® ALIF Spacer is substantially equivalent to its predicates for intervertebral body fusion in regards to intended use, design, materials, and operational principles. Examples of other predicate intervertebral body fusion devices distributed for the similar indications include the Stryker Spine AVS PL-PEEK Spacers (K073470 and K080758) and Synthes' SynFix™-LR (K072253) while the Interpore Cross Expandable PEEK VBR Implant (K040928) has similar design features. Based upon the mechanical testing, the PEEK ALIF is substantially equivalent for its intended use to other spacers currently on the market.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, rendered in a stylized, minimalist design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet Spine % Ms. Vivian Kelly Regulatory Affairs Project Manager 100 Interpace Parkway Parsippany, New Jersey 07054
AUG - 7 2008
Re: K081636
Trade/Device Name: PEEK-OPTIMA® ALIF Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: June 10, 2008 Received: June 11, 2008
Dear Ms. Kelly:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.
2
Page 2 - Ms. Vivian Kelly
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number (if known): K081636
Device Name: PEEK-OPTIMA® ALIF Spacer
Indications for Use:
The PEEK-OPTIMA® ALIF Spacer is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The PEEK-OPTIMA® ALIF Spacer is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Page 1 of 1
Barbara Bueno
al. Restorative, Division of Gener and Neurological Devices
510(k) Number K081636