(61 days)
The eSPIN System 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 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).
The eSPIN System consists of access and positioning instruments to access the disc space and to position the hand-piece for discectomy, a handpiece, disposable cutting tips, a suction tube & alignments guide and electrical motor unit.
The provided text describes the 510(k) summary for NLT SPINE's eSPIN System, a device intended for cutting and grinding intervertebral disc material during discectomy.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (NLT SPINE eSPIN K120553, K130057; Medtronic Inc. Midas Rex K081475) | "Performance testing in bench (e.g. system mechanism durability & functionality) demonstrated that the eSPIN System is substantially equivalent to its predicate." |
| Safety and effectiveness | "The eSPIN System is as safe and effective as its predicate devices." |
| Same intended uses and similar indications, technological characteristics, and principles of operation as predicate devices | "The eSPIN System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device." |
| Minor technological differences with predicate devices raise no new issues of safety or effectiveness | "The minor technological differences between the eSPIN System and its predicate devices raise no new issues of safety or effectiveness." |
2. Sample size used for the test set and the data provenance
The document only states "Performance testing in bench (e.g. system mechanism durability & functionality)". There is no information provided about the specific sample size, country of origin, or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The testing described is "bench testing" focusing on mechanical performance rather than clinical data requiring expert review for ground truth.
4. Adjudication method for the test set
This information is not provided in the document. As the testing was bench-based, no human adjudication of diagnostic or clinical outcomes is mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of an MRMC comparative effectiveness study involving human readers or AI assistance. The device is a surgical instrument, not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the eSPIN System is a surgical instrument, not a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance data reported, the "ground truth" seems to be based on engineering benchmarks and predicate device performance standards as assessed through "bench testing" for "system mechanism durability & functionality." It's about how well the device mechanically performs its intended function, not a diagnostic accuracy against a clinical ground truth.
8. The sample size for the training set
This information is not provided. The device is a physical instrument, and while it might have undergone extensive internal development and testing (which could be considered analogous to a "training set" for an algorithm development, though not typically referred to as such for hardware), the document doesn't detail this.
9. How the ground truth for the training set was established
This information is not provided and is largely not applicable in the context of a physical surgical device's 510(k) submission, which focuses on demonstrating substantial equivalence to predicate devices through engineering and functional testing rather than algorithmic training against a defined ground truth.
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510(k) SUMMARY
NLT SPINE's eSPIN System
K133061 Page 1 of 2
As required by 21 C.F.R. § 807.92
Sponsor:
NLT SPINE Ltd. 6 Yad Harutzim St, Kfar-Saba Israel 4464103
NOV 2 7 2013
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: September 27, 2013
Name of Device: eSPIN System
Common or Usual Name: Arthroscope and Accessories
Classification Name: Arthroscope and Accessories 21 CFR §880.1100 Product Code HRX
Predicate Devices
Intended Use / Indications for Use
The eSPIN System 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 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).
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Image /page/1/Picture/0 description: The image shows the logo for NLT Spine. The logo features a stylized spine graphic on the left, followed by the text "NLTSPine" in a modern, sans-serif font. Below "NLTSPine" is the text "Nonlinear Technologies" in a smaller font. The logo is simple and clean, with a focus on the company's name and its connection to spinal technology.
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Technological Characteristics
K133061 Page 2 of 2
The eSPIN System consists of access and positioning instruments to access the disc space and to position the hand-piece for discectomy, a handpiece, disposable cutting tips, a suction tube & alignments guide and electrical motor unit.
Performance Data
Performance testing in bench (e.g. system mechanism durability & functionality) demonstrated that the eSPIN System is substantially equivalent to its predicate.
Substantial Equivalence
The eSPIN System is as safe and effective as its predicate devices. The eSPIN System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the eSPIN System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the eSPIN System is as safe and effective as its predicate devices. Thus, the eSPIN System is substantially equivalent.
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Image /page/2/Picture/0 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.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
NLT SPINE LTD % John J. Smith, M.D., J.D. Hogan Lovells US LLP 555 Thirteenth Street, Northwest Washington, District of Columbia 20004
Re: K133061
Trade/Device Name: eSPIN System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: September 27, 2013 Received: September 27, 2013
Dated: Sep
Received: September 27,
Dear Dr. 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). and Cosmetion for (100) kee the device, subject to the general controls provisions of the Act. The r ou may, morelove, many of the Act include requirements for annual registration, listing of general condrois provision practice, labeling, and prohibitions against misbranding and advises: 2004 mananate: 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 I 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 of any I coural statutes and registements, 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
November 27, 2013
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Page 2 - John J. Smith, M.D., J.D.
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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 Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.html Also, picase 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/ReportalProblem/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.
For
Sincerely yours.
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):_--
Device Name: eSPIN System
Indications for Use:
The eSPIN System is intended for use in cutting and grinding intervertebral disc material during discectorny 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 × (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 CDRH, Office of Device Evaluation (ODE)
18
§ 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.