(78 days)
P950002
Not Found
No
The summary describes a physical intervertebral body fusion device and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is used to treat degenerative disc disease and facilitate fusion between vertebrae in the spine, which is a therapeutic purpose.
No
The Ardis™ Spacer is an implanted device used for intervertebral body fusion, which is a treatment for degenerative disc disease. It is a medical device used for therapy/treatment, not for diagnosing conditions.
No
The device description clearly states it is a "hollow device intended for use as an intervertebral body fusion device," indicating it is a physical implant, not software.
Based on the provided information, the Ardis™ Spacer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Ardis™ Spacer Function: The Ardis™ Spacer is an implantable device used in spinal fusion surgery. It is a physical object placed within the body to facilitate bone growth and stabilize the spine.
- Intended Use: The intended use clearly describes a surgical procedure involving implantation, not the analysis of biological samples.
- Device Description: The description details a hollow device for intervertebral body fusion, consistent with a surgical implant.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
Therefore, the Ardis™ Spacer falls under the category of a surgical implant or medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Ardis™ Spacer is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment.
The Ardis™ Spacer is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.
Product codes
MAX
Device Description
Ardis™ Spacer is a hollow device intended for use as an intervertebral body fusion device in the lumbosacral region (L2-S1) of the spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbosacral region (L2-S1) of the spine
Indicated Patient Age Range
Patients should be 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)
Engineering evaluations and bench testing were conducted to assess the physical and mechanical properties of the subject device. These results demonstrate that the performance of the Abbott Spine Ardis™ Spacer, when compared with other available intervertebral body fusion devices with similar indications, intended use and materials of manufacture is substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
BAK™ Interbody Fusion System (P950002)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JAN 30 Lan i
ABBOTT SPINE, INC. SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter:
Abbott Spine Inc.
ESTABLISHMENT REGISTRATION Number:
CONTACT PERSON:
1649384
Maritza Elias Requlatory Affairs Specialist Telephone: 512.533.1908 Fax: 512.918.2784
DATE:
Trade Name:
Product Code:
DEVICE CLASSIFICATION:
CLASSIFICATION NAME:
Classification Reference:
PREDICATE DEVICE:
Device Description:
INDICATIONS:
Ardis™ Spacer
January 16, 2008
MAX
Class II
Spinal Intervertebral Body Fusion Device
21 CFR § 888.3080
BAK™ Interbody Fusion System (P950002)
Ardis™ Spacer is a hollow device intended for use as an intervertebral body fusion device in the lumbosacral region (L2-S1) of the spine.
The Ardis™ Spacer is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous nonfusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment.
The Ardis™ Spacer is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.
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1
SUBSTANTIAL EQUIVALENCE:
Engineering evaluations and bench testing were conducted to assess the physical and mechanical properties of the subject device. These results demonstrate that the performance of the Abbott Spine Ardis™ Spacer, when compared with other available intervertebral body fusion devices with similar indications, intended use and materials of manufacture is substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. 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 resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
JAN 30 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Abbott Spine, Inc. % Ms. Maritza Elias Regulatory Affairs Specialist 5301 Riata Park Court, Bldg F Austin, TX 78727
Re: K073202
Trade/Device Name: ArdisTM Spacer Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: November 7, 2007 Received: November 13, 2007
Dear Ms. Elias:
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.
3
Page 2 - Ms. Maritza Elias
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 the reporting 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 toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M Mulkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K073202
Device Name:
Abbott Spine Ardis TM Spacer
Indications for Use:
The Ardis™ Spacer is indicated for use with autogenous bone graff as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment.
The Ardis™ Spacer is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.
Prescription Use X (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
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(Division Sign-Off)
and Neurological Devices
510(k) Number K073202