(112 days)
No
The device description and performance studies focus on mechanical function and material properties, with no mention of AI or ML.
No.
The device is described as a tool for cutting, grinding, and aspirating disc material during discectomy procedures, which are surgical interventions, not therapeutic treatments.
No
The device is described as a discectomy system intended for cutting, grinding, and aspirating intervertebral disc material, which are therapeutic actions, not diagnostic ones.
No
The device description clearly indicates it is a physical, single-use discectomy device with mechanical components (auger mechanism) 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:
- Intended Use: The intended use clearly states the device is for "cutting, grinding and aspirating intervertebral disc material during discectomy procedures." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a mechanical device designed to physically remove tissue.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a person's health.
The enSpire™ Discectomy System is a surgical instrument used in vivo (within the living body) during a surgical procedure.
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
HRX
Device Description
The modified 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 modified enSpire™ Discectorny 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
Direct visualization, fluoroscopic imaging or other imaging modalities
Anatomical Site
cervical, thoracic and lumbar spine.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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 modified enSpire™ Discectomy System performance characteristics were evaluated in the following in-vitro bench studies:
- 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
- · Electromagnetic Compatibility and Electrical Safety
- · Packaging Testing
- · Shipping Testing
- · Sterility Testing
- · Shelf Life Testing
- · Biocompatibility:
- Cytotoxicity ం
- Sensitization o
- Irritation O
- Systemic Toxicity o
- Tissue Volume/Material Removal . No Breach of Annulus or Endplates
Results of the pre-clinical testing demonstrate that the materials chosen, the manufacturing process, and design of the modified enSpire™ Discectomy System meet the established specifications necessary for consistent performance during its intended use. In addition, the testing demonstrates the modified enSpire™ Discectomy System is substantially equivalent to the named predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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.
A. Name, Address, Phone and Fax Number of Applicant
Spine View, Inc. 48810 Kato Road, Suite 100E Fremont, CA 94538 Phone: (510) 623-1931 (510) 490-1753 Fax:
B. Contact Person
Diana DeGregorio Lincé Consulting Regulatory Affairs Consultant (925) 980-8047 dianadegregorio@comcast.net
Alternate Contact: Mbithi Muthini Director Quality and Regulatory (510) 743-5090 mmuthini@spineview.com
C. Date Prepared
March 5, 2012
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 modified enSpire™ Discectomy System is substantially equivalent to the Spine View enSpire™ Discectomy System cleared under K110992 on October 21, 2011.
1
Spine View, Inc.
F. Device Description
The modified 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 modified enSpire™ Discectorny System is supplied as a sterile, single patient use, disposable device.
G. Intended Use
The modified enSpire™ Discectomy System is intended for use in cutting, grinding and aspirating intervertebral disc material during discectorny procedures in the cervical, thoracic and fumbar spine.
H. Technological Comparison
The modified enSpire™ Discectorny System has similar features compared to the predicate devices in the table below.
| Manufacturer | Spine View, Inc. | Spine View, Inc. |
|---|---|---|
| Device Name | enSpire™ Discectomy System | Modified enSpire™ Discectomy System |
| 510(k) Number | K110992 | TBD |
| 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. | Same |
| Product Code | HRX | |
| Arthroscope, 21CFR888.1100, Class II, (Debrider) | Same | |
| Principal Operator | Physician | Same |
| Use Location | Operating Room or Medical Suite | Same |
| Operating Principal | Percutaneous, endoscopic or open surgical Discectomy system with standard surgical accessories | Same |
| Functions of Included Devices | Dilatation | |
| Access | ||
| Excision | ||
| Aspiration | Same | |
| Mechanics of Action | Activating the device causes the cutting mechanism to expand and rotate and auger to rotate to cut and grind the disc material, which is then aspirated down the working shaft of the device and collected in the collection chamber | Activating the device causes the auger to rotate against the entrapped tissue and fixed cutting mechanism to cut and grind the disc material, which is then aspirated down the working shaft of the device and collected in the collection chamber |
| Target Anatomy | Cervical, Thoracic and Lumbar spinal segments | Same |
| Design Features | Auger housed in a tube with expandable rotating cutting assembly (spiral wire or curette style cutter) on the distal end. Driven by a battery-powered motor that is housed in a plastic handle at the proximal end of the device. | Auger housed in a tube with a non-expandable Serrated Cutting Window at the distal end. Driven by a battery-powered motor that is housed in a plastic handle at the proximal end of the device. |
| Manufacturer | Spine View, Inc. | Spine View, Inc. |
| Device Name | enSpire™ Discectomy System | Modified enSpire™ Discectomy System, |
| 510(k) Number | K110992 device. | TBD |
| 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. | 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. | ||
| The device contains a straight, curved or | ||
| articulating working shaft. | The device contains a straight or articulating | |
| working shaft. | ||
| Expandable spiral wire and a curette style | ||
| cutter | ||
| Sweep Diameter (Expanded): 0.280 - 0.390" | Non-Expandable Serrated Cutting Windows | |
| SV3309: 0.075" x 0.240" x 2 windows | ||
| SV1107: 0.055" x 0.170" x 2 windows | ||
| Tip Materials | PEEK, Aramid Fiber, Polyimide, Stainless | |
| Steel, and Tungsten | Stainless Steel | |
| Sterile Packaging | 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. | Same | |
| Sterilization Method | Gamma | Same |
| Biocompatible for | ||
| Intended Use | Yes | Yes |
| Single use | Yes | Yes |
| Configuration | Straight, Curved, Articulating | Straight or Articulating |
| Handle Design | Hand-held rotary device, in-line or pistol-grip | |
| handle | Same | |
| Profile | 0.046-0.165" OD working shaft with tip | |
| 0.280-0.400" OD deployed, 0.058-0.220" OD | ||
| unexpanded | 0.058-0.110" OD shaft diameter at tip | |
| Working Length | 2 -22" working length | 2 -9" working length |
| Energy Type | Mechanical | Same |
| Power | Battery, 9V or 18V | Same |
| Meets Applicable | ||
| IEC60601-1 testing | Yes | Yes |
| User visualization/guidance | Direct visualization, fluoroscopic imaging or | |
| other imaging modalities | Same |
2
Spine View, Inc.
K120680
The technological characteristics and principals of operation of the modified enSpire™ Discectomy System are substantially equivalent to the named predicate device.
i. Summary of Non-Clinical Data
The modified enSpire™ Discectomy System performance characteristics were evaluated in the following in-vitro bench studies:
3
- 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
- · Electromagnetic Compatibility and Electrical Safety
- · Packaging Testing
- · Shipping Testing
- · Sterility Testing
- · Shelf Life Testing
- · Biocompatibility:
- Cytotoxicity ం
- Sensitization o
- Irritation O
- Systemic Toxicity o
- Tissue Volume/Material Removal . No Breach of Annulus or Endplates
Results of the pre-clinical testing demonstrate that the materials chosen, the manufacturing process, and design of the modified enSpire™ Discectomy System meet the established specifications necessary for consistent performance during its intended use. In addition, the testing demonstrates the modified enSpire™ Discectomy System is substantially equivalent to the named predicate.
J. Summary of Data
.
The modified 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 modified enSpire™ Discectomy System performs as intended and meets the design specifications. The non-clinical performance testing and comparison to the predicate device demonstrate that the modified enSpire™ Discectomy System is substantially equivalent to the predicate device and does not raise new issues of safety or effectiveness.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Spine View, Incorporated % Ms. Diana DeGregorio Regulatory Affairs Consultant 48810 Kato Road Suite 100E Fremont, California 94538
Re: K120680
Trade/Device Name: enSpire™ Discectomy System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope & Accessory Regulatory Class: Class II Product Code: HRX Dated: June 15, 2012 Received: June 18, 2012
Dear Ms. DeGregorio:
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 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 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
JUN 2 6 2012
5
Page 2 - Ms. Diana DeGregorio
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 yours,
for Math Dar
or
Mark N. Melke Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
510(k) Number (if known): K_K12 06 80
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 discectorny 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)
Niel R.P. Ogden for mkn
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
. 510(k) Number K120680