(78 days)
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.
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 provided text is a 510(k) summary for a medical device called the Ardis™ Spacer. It describes the device, its indications for use, and states that substantial equivalence was demonstrated through engineering evaluations and bench testing.
However, the document does not contain any information regarding acceptance criteria, reported device performance metrics (like sensitivity, specificity, or accuracy), or details about a study that would demonstrate the device meets such criteria in terms of clinical performance.
Here's why the requested information cannot be fully provided from the given text:
- Type of Device: The Ardis™ Spacer is a physical implant (intervertebral body fusion device), not an AI/software-as-a-medical-device (SaMD) or diagnostic device that would typically have performance metrics like sensitivity or specificity.
- Study Type: The submission focuses on demonstrating "substantial equivalence" to a predicate device primarily through "engineering evaluations and bench testing" to assess "physical and mechanical properties." It's not a clinical effectiveness study in the way one would assess a diagnostic algorithm.
- Clinical Performance Data Absence: There's no mention of a study involving human subjects, data sets for training or testing algorithms, expert opinions for ground truth, or statistical measures of diagnostic performance.
Therefore, most of the requested fields are not applicable or cannot be extracted from this document.
Based only on the provided text, here's what can be answered:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical and Mechanical Properties as compared to other available intervertebral body fusion devices. | "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." (Implicitly, the device met the criteria by being substantially equivalent.) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The submission refers to "engineering evaluations and bench testing," not a clinical test set with human data. Therefore, there's no sample size in this context, nor data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. Ground truth, in the context of clinical performance for diagnostic or AI devices, is not discussed in this submission. The "ground truth" here would relate to the successful physical and mechanical performance defined by engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. There is no clinical test set described that would require adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI-assisted device. No MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The implicit "ground truth" for the substantial equivalence claim is based on engineering standards and established performance characteristics of predicate intervertebral body fusion devices.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device, so there is no training set or associated ground truth establishment.
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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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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.
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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.
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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
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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
§ 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.