(42 days)
Not Found
Not Found
No
The device description and intended use focus on mechanical tools for biopsy and cement delivery. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The device is described as a biopsy tool and a cement dispenser, both diagnostic and procedural tools, not explicitly a therapeutic device designed to treat a disease or condition. While the cement dispensing aspect is part of a "vertebroplasty procedure" for "vertebral body augmentation," the primary described uses are for diagnosis (biopsy) and augmentation rather than direct therapy for a medical condition.
Yes
The device is described as "a stand alone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes". Biopsy for diagnostic purposes indicates it is a diagnostic device.
No
The device description explicitly lists physical components such as aspiration/injection taps, handles, needles, awls, ports, dilators, a Luer cap, and k-wire, indicating it is a hardware-based medical device.
Based on the provided information, the Abbott Spine Spinnaker System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a tool to remove a sample of bone tissue for diagnostic purposes and to dispense cement. It's a surgical tool used on the patient to obtain a sample and perform a procedure.
- Device Description: The description lists components like needles, handles, awls, ports, etc., which are all surgical instruments.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze a sample in vitro (outside the body). IVDs typically involve reagents, analyzers, or other components used to perform tests on biological samples like blood, urine, or tissue after they have been collected.
The device is used to obtain the sample, but the diagnostic testing of that sample would be performed separately, likely using IVD devices or laboratory procedures.
N/A
Intended Use / Indications for Use
The Abbott Spine Spinnaker System is intended for use as a stand alone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site.
When used as a cement dispenser, the Spinnaker System is intended to dispense cement cleared for use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.
Product codes
KNW, KIH
Device Description
The Abbott Spine, Inc. Spinnaker System is intended for use as a vertebral body biopsy and cement dispenser device. The system is comprised of aspiration/injection taps, handles, a targeting needle, a bone awl, ports and dilators, a Luer cap, and k-wire. The system provides the surgeon with a convenient method of performing vertebral body bone biopsy, as well as dispensing cement cleared for use in the spine into a vertebral body using a single system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vertebral body / spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
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)
Mechanical testing demonstrated that the Spinnaker System exhibits the functional requirements to support its use for performing vertebral body bone biopsy and dispensing cement into a vertebral body for vertebral body augmentation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Stryker Capture Vertebral Body and Bone Biopsy Kit, Parallax Medical Core-Assure Bone and Vertebral Body Biopsy Kit
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
K 052638
Abbott Spine, Inc. Spinnaker System
510(k) Summary of Safety and Effectiveness
| SUBMITTED BY | Abbott Spine, Inc.
5301 Riata Park Court, Bldg. F
Austin, TX 78727 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ESTABLISHMENT
REGISTRATION NUMBER | 1649384 |
| CONTACT PERSON | Lisa Peterson
Regulatory Affairs Manager
Phone: 512-533-1080
Fax: 512-249-6734 |
| DATE PREPARED | September 19, 2005 |
| CLASSIFICATION NAME | KNW 876.1075- Gastroenterology-Urology Biopsy
Instrument: Class II
KIH 888.4200- Cement Dispenser: Class I |
| COMMON NAME | Vertebral Body Biopsy Needle
Cement Dispenser |
| PROPRIETARY NAME | Abbott Spine Inc. Spinnaker System |
| SUBSTANTIAL
EQUIVALENCE | The Abbott Spine Spinnaker System was determined to
be substantially equivalent to the Stryker Capture
Vertebral Body and Bone Biopsy Kit and the Parallax
Medical Core-Assure Bone and Vertebral Body Biopsy
Kit. |
DEVICE DESCRIPTION:
The Abbott Spine, Inc. Spinnaker System is intended for use as a vertebral body biopsy and cement dispenser device. The system is comprised of aspiration/injection taps, handles, a targeting needle, a bone awl, ports and dilators, a Luer cap, and k-wire. The system provides the surgeon with a convenient method of performing vertebral body bone biopsy, as well as dispensing cement cleared for use in the spine into a vertebral body using a single system.
Abbott Spine, Inc.
1
INDICATIONS:
The Abbott Spine Spinnaker System is intended for use as a stand alone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site.
When used as a cement dispenser, the Spinnaker System is intended to dispense cement cleared for use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.
MECHANICAL TEST DATA
Mechanical testing demonstrated that the Spinnaker System exhibits the functional requirements to support its use for performing vertebral body bone biopsy and dispensing cement into a vertebral body for vertebral body augmentation.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 7 2005
Lisa Peterson Abbott Spine, Inc. Regulatory Affairs Manager 5301 Riata Park Court, Building F Austin, Texas 78727
Re: K052638
Trade/Device Name: Spinnaker System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW, KIH Dated: September 19, 2005 Received: September 27, 2005
Dear Ms. Peterson:
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 -Lisa Peterson
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 Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Signature
Sark N. Melkerson Acting 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):
KOS2638
Abbott Spine, Inc. Spinnaker System Device Name:
Indications for Use:
The Abbott Spine Spinnaker System is intended for use as a stand alone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site.
When used as a cement dispenser, the Spinnaker System is intended to dispense cement cleared for use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.
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)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K05 2638