(70 days)
Not Found
No
The description focuses on mechanical cutting, grinding, and aspiration, with no mention of AI, ML, image processing, or data-driven decision making.
No.
The device is described as a surgical tool for cutting, grinding, and aspirating disc material, which is an interventional procedure rather than a therapeutic treatment in itself. Its function is to remove tissue.
No
The device is described as a debrider intended for cutting, grinding, and aspirating intervertebral disc material during discectomy procedures. This is a therapeutic function, not a diagnostic one.
No
The device description clearly indicates a physical, single-use discectomy device with a mechanical auger for cutting, grinding, and aspirating tissue. This is a hardware device, not software only.
Based on the provided information, the SpineView ENSPIRE™ Debrider is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "cutting, grinding and aspirating intervertebral disc material during discectomy procedures." This describes a surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a mechanical device designed to physically remove tissue. This is consistent with a surgical instrument, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting specific substances, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The SpineView ENSPIRE™ Debrider is a surgical tool used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
The SpineView ENSPIRE™ Debrider is intended for use in cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
HRX
Device Description
The SpineView ENSPIRE™ Debrider is a single-use discectomy device that is designed to cut and grind intervertebral disc material. Its auger mechaeo mechaeo um retrieves the excised debris and ejects it into a collection chamber.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical, thoracic and lumbar spine
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)
Biocompatibility testing demonstrates that the device is in compliance with ISO 10993.
Bench testing has demonstrated that the device is in compliance with the pertinent standards, the expectations of the medical community and the product labeling.
Cadaver testing demonstrated that the device can be used as intended in humans.
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.
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
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. 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 § 888.9.
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K090278
Page 1 of
SpineView, Inc.
APR 1 5 2009 ENSPIRE™ Debrider System Traditional 510(k) Premarket Notification
Section 5: 510(k) Summary
2
Device Information:
| Category | Comments |
|---|---|
| Sponsor: | Spine View, Inc. |
| 48541-Warm Springs Blvd., Suite 507 | |
| Fremont, CA 94539 | |
| Correspondent Contact | |
| Information: | Sandra Sundell |
| Director, Regulatory Affairs | |
| SpineView, Inc. | |
| 48541 Warm Springs Blvd., Suite 507 | |
| Fremont, CA 94539 | |
| Tel: 510 585-5345 | |
| Fax: 510 623-1093 | |
| Email:ssundell@spineview.com | |
| Device Common Name: | Arthroscope and Accessories |
| Device Classification & | |
| Code: | Arthroscope: Class II, HRX |
| Arthroscope Accessories: Class I, NBH | |
| Device Classification | |
| Name: | 21 CFR § 888.1100 Arthroscope and |
| Accessories | |
| Device Proprietary Name: | ENSPIRE™ Debrider System |
Predicate Device Information:
| Predicate Devices: | Stryker Dekompressor
Percutaneous Discectomy
Probe | SpineVu Endoscopic Spine
System (SESS) |
|--------------------------------------------|-------------------------------------------------------------------|---------------------------------------------|
| Predicate Device
Manufacturers: | Stryker Instruments | SpineView, Inc. |
| K#s | K032473 | K081051 |
| Predicate Device Common
Name: | Percutaneous Discectomy
Probe Arthroscopic
Intervention Kit | Arthroscopic Intervention Kit |
| Predicate Device
Classification: | 21CFR888.1100:
Arthroscope & Accessories | 21CFR888.1100: Arthroscope
& Accessories |
| Predicate Device
Classification & Code: | Class II, HRX | Class II, HRX |
b. Date Summary Prepared
February 3, 2009
Description of Device C.
The SpineView ENSPIRE™ Debrider is a single-use discectomy device that is designed to cut and grind intervertebral disc material. Its auger mechaeo mechaeo um retrieves the excised debris and ejects it into a collection chamber.
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SpineView, Inc.
d. Intended Use
The SpineView ENSPIRE™ Debrider is intended for use in cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine.
e. Comparison to Predicate Device
The SpineView ENSPIRE™ Debrider is substantially equivalent in intended use and technology to the currently marketed predicate devices the Debrider component of the SpineVu Endoscopic Spine System (K081051) and the Stryker Dekompressor Percutaneous Discectomy Probe (K032473). Both the Application device and the predicate devices provide a means to aspirate and grind disc material during discectomies in the lumbar, thoracic and cervical regions of the spine. The SpineView ENSPIRE™ Debrider and the predicate devices are all intended to be used to cut and remove diseased disc material in the same anatomical location.
f. Summary of Supporting Data
Biocompatibility testing demonstrates that the device is in compliance with ISO 10993.
Bench testing has demonstrated that the device is in compliance with the pertinent standards, the expectations of the medical community and the product labeling.
Cadaver testing demonstrated that the device can be used as intended in humans.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Spine View, Inc. % Ms. Sandra Sundell Director, Regulatory Affairs 48541 Warm Springs Boulevard Suite 507 Fremont, California 94539
APR 1 5 2009
Re: K090278
Trade/Device Name: ENSPIRE™ Debrider System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Product Code: HRX Dated: March 23, 2009 Received: March 24, 2009
Dear Ms. Sundell:
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 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 of medical device-related adverse events) (21 CFR 803); 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.
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
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Page 2 - Ms. Sandra Sundell
(240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
for Don Rim
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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SpineView, Inc.
Section 4: Indications for Use Statement
510(k) Number (if known):
Device Name: ENSPIRE™ Debrider System
Indications For Use: The SpineView ENSPIRE™ Debrider is intended for use in cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine.
Prescription Use X (Part 21 CFR 801 Subpart D) 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)
Neil R.R. Oglesby L.r.m.x.m
Page 1 of
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
AND/OR
510(k) Number K090278