(196 days)
Not Found
No
The summary describes a mechanical device for cutting and removing disc material. There is no mention of AI/ML terms, image processing for analysis, or data sets for training/testing algorithms.
No
A therapeutic device is used to treat or alleviate a disease or condition. This device is used during a discectomy procedure to cut, grind, and aspirate disc material, which is a surgical tool, not a therapeutic device.
No
The device is described as a system for "cutting, grinding and aspirating intervertebral disc material," which are surgical, not diagnostic, procedures.
No
The device description clearly indicates it is a physical, single-use discectomy device with mechanical components (auger mechanism, collection chamber) designed to cut, grind, and aspirate tissue. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The enSpire™ Discectomy System is a surgical tool designed to physically cut, grind, and aspirate intervertebral disc material during a surgical procedure. It is used directly on the patient's body, not on a specimen taken from the body.
- Intended Use: The intended use clearly states it's for "cutting, grinding and aspirating intervertebral disc material during discectomy procedures." This is a surgical intervention, not a diagnostic test performed on a sample.
The device is a surgical instrument used for treatment, not for diagnosing a condition by analyzing a sample.
N/A
Intended Use / Indications for Use
The enSpire™ Discectomy System 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 enSpire™ Discectomy System is a single-use discectomy device that is designed to cut and grind intervertebral disc material. An auger mechanism retrieves the excised debris and ejects it into a collection chamber. The enSpire™ Discectomy System is supplied as a sterile, single patient use, disposable device.
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
Physician; Operating Room or Medical Suite
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)
The enSpire™ Discectomy System performance characteristics were evaluated in the following in-vitro bench studies: Tissue Removal, Cannula Compatibility, Enable Switch Durability, Deployment & Retraction, Working Shaft Length, Device Durability, Travel Limiter Attachment, Travel Limiter, Tensile Strength, Articulation Function, Articulation Angle, Visualization, Peak Temperature during Operation, Tissue Volume/Material Removal, No Breach of Annulus or Endplates.
Additional tests: Electromagnetic Compatibility and Electrical Safety, Packaging Testing, Shipping Testing, Sterility Testing, Shelf Life Testing, Biocompatibility (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity).
Results of the pre-clinical testing demonstrate that the materials chosen, the manufacturing process, and design of the enSpire™ Discectomy System meet the established specifications necessary for consistent performance during its intended use. In addition, the testing demonstrates the enSpire™ Discectomy System is substantially equivalent to the named predicate.
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.
0
Traditional 510(k) enSpire™ Discectomy System
510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Name, Address, Phone and Fax Number of Applicant A.
Spine View, Inc. 48810 Kato Road, Suite 100E Fremont, CA 94538 Phone: (510) 623-1931 (510) 490-1753 Fax:
B. Contact Person
Mbithi Muthini Director Quality and Regulatory (510) 743-5090 mmuthini@spineview.com
Alternate Contact: Diana DeGregorio Lincé Consulting Regulatory Affairs Consultant (925) 980-8047 dianadegregorio@comcast.net
C. Date Prepared
April 7, 2011
D. Device Name
| Trade Name: | enSpire™ Discectomy System |
|---|---|
| Common Name: | Arthroscope & Accessory |
| Classification Name: | Arthroscope & Accessories (21 CFR §888.1100, Product Code HRX) |
E. Predicate Devices
The enSpire™ Discectomy System is substantially equivalent to the Spine View enSpire™ Debrider System cleared under K090278 on April 15, 2009.
· · ()
1
Kllo992
Spine View, Inc.
F. Device Description
The enSpire™ Discectomy System is a single-use discectomy device that is designed to cut and grind intervertebral disc material. An auger mechanism retrieves the excised debris and ejects it into a collection chamber.
The enSpire™ Discectomy System is supplied as a sterile, single patient use, disposable device.
G. Intended Use
The enSpire™ Discectomy System is intended for use in cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine.
H. Technological Comparison
The enSpire™ Discectomy System has similar features as compared to the predicate devices in the table below.
| Feature | Spine View, Inc.
Spine View ENSPIRE™ Debrider
System
K090278 | Spine View, Inc.
enSpire™ Discectomy System
K110992 |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Spine View. ENSPIRE™ Debrider is intended for use in cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine. | The enSpire™ Discectomy System is intended for use in cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine. |
| Product Code | HRX
Arthroscope, 21CFR888.1100, Class II, (Debrider)
NBH, Class I exempt (Introducer Cannula with Stylet) | HRX
Arthroscope, 21CFR888.1100, Class II, (Debrider)
NBH, Class I exempt (Introducer Cannula with Stylet) |
| Principal Operator | Physician | Physician |
| Use Location | Operating Room or Medical Suite | Operating Room or Medical Suite |
| Operating Principal | Percutaneous, endoscopic or open surgical Discectomy system with standard surgical accessories | Percutaneous, endoscopic or open surgical Discectomy system with standard surgical accessories |
| Functions of Included
Devices | Dilatation
Access
Excision
Aspiration | Dilatation
Access
Excision
Aspiration |
| Mechanics of Action | Percutaneous, endoscopic or open surgical Discectomy System with standard surgical accessories | Percutaneous, endoscopic or open surgical Discectomy System with standard surgical accessories |
| Target Anatomy | Intervertebral procedure | Intervertebral procedure |
| Design Features | Auger housed in a tube, with retractable cutting assembly (spiral | Auger housed in a tube, with retractable rotating cutting assembly (spiral wire or |
| Feature | Spine View, Inc.
Spine View ENSPIRE™ Debrider
System
K090278 | Spine View, Inc.
enSpire™ Discectomy System
K110992 |
| | wire) on the distal end. It is driven by
a battery-powered motor that is
housed in a plastic handle at the
proximal end of the device.
Cut debris can pass up the tube and
into the collection chamber located at
the end of the auger. It is inserted
into the surgical site either directly,
via an introducer cannula or
Arthroscope.
Working Shaft straight. | curette style cutter) on the distal end. It
is driven by a battery-powered motor that
is housed in a plastic handle at the
proximal end of the device.
Cut debris can pass up the tube and into
the collection chamber located at the
end of the auger. It is inserted into the
surgical site either directly, via an
introducer cannula or Arthroscope.
Working shaft: straight, curved or
articulating. |
| Tip Materials | Stainless Steel and Solder | PEEK, Aramid Fiber, Polyimide,
Stainless Steel, and Tungsten |
| Sterile Packaging | The ENSPIRE™ Debrider System is
placed onto a polyethylene card and
sealed in a Tyvek/Mylar pouch. That
pouch is placed into a whiteboard
unit carton. | The enSpire™ Discectomy System is
placed into a thermo formed tray with a
thermoformed insert lid, and sealed with
a Tyvek tray lid. The sealed tray is then
placed in a labeled chip board shelf
carton. |
| Sterilization Method | Electron Beam | Gamma |
| Biocompatible for
Intended Use | Yes | Yes |
| Single use | Yes | Yes |
| Configuration | Straight | Straight, Curved, Articulating |
| Handle Design | Hand-held rotary device, in-line grip | Hand-held rotary device, in-line grip or
pistol-grip |
| Profile | 0.046" OD working shaft with tip
0.27" OD deployed, 0.052" OD
unexpanded. | 0.046-0.165" OD working shaft with tip
0.28-0.40" OD deployed, 0.058-0.22" OD
unexpanded |
| Working Length | 8 - 11" working length | 2 - 22" working length |
| Energy Type | Mechanical | Mechanical |
| Power | Battery, 9V | Battery, 9V or 18V |
| Meets Applicable
IEC60601-1 testing | Yes | Yes |
| User
visualization/guidance | Direct visualization, fluoroscopic
imaging | Direct visualization, fluoroscopic imaging |
.
Appendix A, Page 2 of 4
2
Spine View, Inc.
Traditional 510(k) enSpire™ Discectomy System
The technological characteristics and principals of operation of the enSpire™ Discectomy System are substantially equivalent to the named predicate device.
l. Summary of Non-Clinical Data
The enSpire™ Discectomy System performance characteristics were evaluated in the following in-vitro bench studies:
3
4110992
Spine View, Inc.
Traditional 510(k) enSpire™ Discectomy System
- Tissue Removal ●
- Cannula Compatibility .
- Enable Switch Durability .
- . Deployment & Retraction
- Working Shaft Length .
- . Device Durability
- . Travel Limiter Attachment
- . Travel Limiter
- Tensile Strength .
- Articulation Function .
- . Articulation Angle
- Visualization .
- Peak Temperature during . Operation
Tissue Volume/Material Removal
No Breach of Annulus or Endplates
- · Electromagnetic Compatibility and Electrical Safety
- · Packaging Testing
- · Shipping Testing
- · Sterility Testing
- · Shelf Life Testing
- · Biocompatibility:
- Cytotoxicity o
- Sensitization O
- Irritation 0
- Systemic Toxicity 0
Results of the pre-clinical testing demonstrate that the materials chosen, the manufacturing process, and design of the enSpire™ Discectorny System meet the established specifications necessary for consistent performance during its intended use. In addition, the testing demonstrates the enSpire™ Discectomy System is substantially equivalent to the named predicate.
J. Summary of Data
.
.
The enSpire™ Discectomy System has been carefully compared to a legally marketed device with respect to intended use and technological characteristics. In addition, non-clinical testing was conducted to validate the performance of the device and ensure the enSpire™ Discectorny System performs as intended and meets the design specifications. The non-clinical performance testing and comparison to the predicate device demonstrate that the enSpire™ Discectomy System is substantially equivalent to the predicate device and does not raise new issues of safety or effectiveness.
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus, indicating the department's name and country.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 1 2011
Spine View, Inc. % Mr. Mbithi Muthini Director, Quality and Regulatory 48810 Kato Road, Suite 100E Fremont, California 94538
Re: K110992
Trade/Device Name: enSpire™ Discectomy System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: September 20, 2011 Received: September 22, 2011
Dear Mr. Muthini:
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 Amendmouts, 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 note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
5
Page 2 - Mr. Mbithi Muthini
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Eriel Keith
Cor Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Spine View, Inc.
Indications for Use Statement
510(k) Number (if known):
K110992 K
Device Name: enSpire™ Discectomy System
Indications for Use:
The enSpire™ Discectomy System is intended for use in cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine.
Prescription Use × OR
Over-The-Counter Use
(per 21 CFR 801.109)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil RP Ogden for MKN
Division Sign Off
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110992