(168 days)
Not Found
No
The 510(k) summary describes a mechanical cutting and grinding device and does not mention any AI or ML components or functionalities.
No.
The device is used to cut and grind disc material during discectomy, which is a surgical procedure, not a therapeutic treatment for a disease.
No.
The device is described as an instrument for cutting and grinding intervertebral disc material during discectomy procedures, which is a surgical treatment, not a diagnostic process.
No
The device description explicitly states it consists of a hand-held instrument, disposable tips, a motor adaptor, and requires connection to an electrical motor, indicating it is a hardware-based system.
Based on the provided information, the eSpin device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the eSpin is for cutting and grinding intervertebral disc material during discectomy for fusion procedures. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device description details a powered system with a hand-held instrument, disposable tips, and a motor adaptor. This is consistent with a surgical tool.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, or urine) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. The eSpin is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
The eSpin is intended for use in cutting and grinding intervertebral disc material during discectomy for fusion procedures in L2-S1 spinal segments in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e. posterior pedicle screw and rod systems).
Product codes
HRX
Device Description
The eSpin powered system consists of a hand-held instrument (manipulator unit), a set of disposable tips, and a motor adaptor. In addition, set of instruments are to access the disc space and to position the manipulator for discectomy. The eSpin needs to be connected to an Electrical Motor. The required motor specifications are provided in the eSpin User Manual.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1 spinal segments
Indicated Patient Age Range
skeletally mature patients
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)
Performance testing in bench and cadaver models demonstrated that the eSpin is substantially equivalent to its predicate. The company's bench and cadaver testing demonstrate that the eSpin is as safe and effective as its 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
NLT SPINE eSpin Traditional 510(k) Premarket Notification
510(k) SUMMARY
As required by 21 C.F.R. § 807.92
Sponsor:
NLT SPINE Ltd. 6 Yad Harutzim St. Kfar-Saba lsrael 44641
Contact Person:
Eti Zinger Regulatory Affairs Director NLT SPINE Ltd. Tel: +972-3-6344514 Fax: +972-3-6341599 Eti.z@nlt-spine.com
Date Prepared: August 10, 2012 - .
Name of Device: eSpin
Common or Usual Name: Arthroscope and Accessories
Classification Name: Arthroscope and Accessories 21 CFR §888.1100 Product Code HRX
Predicate Devices
- . Spine View enSpire Discectomy System (K110992)
Intended Use / Indications for Use
The eSpin is intended for use in cutting and grinding intervertebral disc material during discectomy for fusion procedures in L2-S1 spinal segments in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e. posterior pedicle screw and rod systems).
Page 1 of 2
Image /page/0/Picture/19 description: The image shows the logo for NLT Spine. The logo consists of a stylized spine graphic on the left, followed by the text "NLTSPINE" in a bold, sans-serif font. Below "NLTSPINE" is the text "NonLinear Technologies" in a smaller, sans-serif font.
AUG 9 2012
1
Technological Characteristics
The eSpin powered system consists of a hand-held instrument (manipulator unit), a set of disposable tips, and a motor adaptor. In addition, set of instruments are to access the disc space and to position the manipulator for discectomy. The eSpin needs to be connected to an Electrical Motor. The required motor specifications are provided in the eSpin User Manual.
Performance Data
Performance testing in bench and cadaver models demonstrated that the eSpin is substantially equivalent to its predicate.
Substantial Equivalence
The eSpin is as safe and effective as its predicate device. The eSpin has substantially similar indications for use and technological characteristics as compared to the predicate device. Any minor differences between the device and the predicate do not raise new questions of safety and effectiveness. The company's bench and cadaver testing demonstrate that the eSpin is as safe and effective as its predicate.
Page 2 of 2
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
9 2012 AUG
NLT Spine Limited % Hogan & Lovells US, LLP Mr. John J. Smith 555 Thirteenth Street, Northwest Washington, District of Columbia 20004
Re: K120553
Trade/Device Name: eSpin Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope and Accessories Regulatory Class: II Product Code: HRX Dated: August 09, 2012 Received: August 09, 2012
Dear Mr. Smith:
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
3
Page 2 - Mr. John J. Smith
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/ResourcesforYou/Industry/default.htm.
Sincerely yours
Mark N. Malkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):__ K120553
Device Name: eSpin
Indications for Use:
The eSpin is intended for use in cutting and grinding intervertebral disc material during discectomy for fusion procedures in L2-S1 spinal segments in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e. posterior pedicle screw and rod systems).
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | |
|---|---|
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of (Division Sign-Off) | |
|---|---|
| (ODRH, Office of Device Evaluation (ODE)) | |
| Division of Surgical, Orthopedic, and Restorative Devices | |
| Page | _ of _ |
| 510(k) Number | 14120533 |
| Page | Page 1 of 1 |