(29 days)
Not Found
No
The summary does not mention AI, ML, or related concepts, and the device description focuses on mechanical components and modifications.
No.
The device is described as a surgical instrument used for cutting and grinding disc material during discectomy procedures, intended to be used with other spinal fixation systems. It is an operative tool, not a device that directly treats or heals a condition.
No
The eSPIN is a surgical device used for cutting and grinding intervertebral disc material during discectomy procedures, it is not used to diagnose a medical condition.
No
The device description explicitly states it consists of a hand-held instrument, disposable tips, a motor connection, and other physical instruments, indicating it is a hardware device, not software-only.
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 on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The device is described as a powered surgical instrument with disposable tips, designed for direct connection to a motor or drill. This aligns with a surgical tool, not a diagnostic device that analyzes biological samples.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (like blood, tissue, or urine) or to provide diagnostic information about a patient's condition. Its function is purely mechanical – to remove disc material.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The eSPIN's function falls outside of this definition.
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 (comma separated list FDA assigned to the subject device)
HRX
Device Description
The eSPIN powered system consists of a hand-held instrument (manipulator unit), a set of disposable tips, and direct connection to a motor via motor adaptor. In addition, set of instruments are to access the disc space and to position the manipulator unit for discectomy. The eSPIN needs to be connected to an electrical motor or drill. The required motor/drill 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
Principal Operator: Physician
Use Location: 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 following testing demonstrated that the eSPIN is substantially equivalent to its predicate:
- . Bending mechanism durability of manipulator unit
- Verification of tip bending angle .
- Verification of discectomy cleaning work limits ●
- Verification of motor parameters .
- . Tip attachment strength under tensile force
- . Durability of tip bristle and tip under rotational and tensile loading
- Biocompatibility evaluation in accordance with ISO 10993 .
- Cadaver studies to evaluate whether the device breaches annulus and confirm radiopacity of . tip under X-ray
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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FEB 0 7 2013
510(k) SUMMARY NLT SPINE's eSPIN
Sponsor:
NLT SPINE Ltd. 6 Yad Harutzim St. Kfar-Saba Israel 44641
Contact Person:
Eti Zinger Regulatory Affairs Director NLT SPINE Ltd. Tel: +972-3-6344514 Fax: +972-3-6341599 Eti.z@nlt-spine.com
February 6, 2013 Date Prepared:
Name of Device: eSPIN
Common or Usual Name: Arthroscope and Accessories
Classification Name: Arthroscope and Accessories 21 CFR §880.1100 Product Code: HRX
Predicate Devices:
NLT SPINE's eSPIN (K120553)
Purpose of the Special 510(k) notice:
The eSPIN is a modification to previously cleared K120553 eSPIN and can be compared to the cleared device as follows:
| Feature | Predicate
NLT SPINE eSPIN Discectomy
System (K120553) | Modified
NLT SPINE eSPIN Discectomy
System |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Intended Use and
Indication | 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 | Same |
| Feature | Predicate
NLT SPINE eSPIN Discectomy
System (K120553) | Modified
NLT SPINE eSPIN Discectomy
System |
| | 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 Code | HRX Arthroscope, 21 CFR 888.1100,
Class II | Same |
| Principal Operator | Physician | Same |
| Use Location | Operating room or Medical Suite | Same |
| Operating Principal | Percutaneous or open surgical
Discectomy system with standard
surgical accessories | Same |
| Functions of Included
Devices | Dilatation
Access
Excision | Dilatation
Access
Excision
Irrigation
Suction |
| Mechanics of Action | Percutaneous or open surgical
Discectomy system with standard
surgical accessories | Same |
| Target Anatomy | Intervertebral procedure for L2-S1
spinal segments | Same |
| Biocompatibility for
Intended Use | Yes | Yes |
| Single Use | Yes (Tips) | Yes (Tips) |
| Configuration | Straight during insertion, and curved
during rotation by its articulation | Straight during insertion, and curved
during rotation by its articulation |
1
Intended 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.
2
Page 3 of 3
Technological Characteristics
11
The eSPIN powered system consists of a hand-held instrument (manipulator unit), a set of disposable tips, and direct connection to a motor via motor adaptor. In addition, set of instruments are to access the disc space and to position the manipulator unit for discectomy. The eSPIN needs to be connected to an electrical motor or drill. The required motor/drill specifications are provided in the eSPIN User Manual.
The primary changes from the cleared eSPIN are:
- Addition of Suction tube and irrigation system .
- . Minor modifications to the device design
Performance Data
The following testing demonstrated that the eSPIN is substantially equivalent to its predicate:
- . Bending mechanism durability of manipulator unit
- Verification of tip bending angle .
- Verification of discectomy cleaning work limits ●
- Verification of motor parameters .
- . Tip attachment strength under tensile force
- . Durability of tip bristle and tip under rotational and tensile loading
- Biocompatibility evaluation in accordance with ISO 10993 .
- Cadaver studies to evaluate whether the device breaches annulus and confirm radiopacity of . tip under X-ray
Substantial Equivalence
.
The eSPIN has the same intended use and indications, principles of operation, and technological characteristics as the predicate. The minor differences in the eSPIN technological characteristics do not raise any new questions of safety or effectiveness. Performance data demonstrates that the eSPIN is as safe and effective as the predicate. Thus, the eSPIN is substantially equivalent to its predicate device.
3
Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal 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
February 7, 2013
NLT Spine. Limited % Hogan and Lovells US, LLP Dr. John Smith 555 Thirteenth Street, Northwest Washington, District of Columbia 20004
Re: K130057
Trade/Device Name: eSPIN Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: January 09, 2013 Received: January 09, 2013
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). 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. Iisting 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 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
4
Page 2 - Dr. John Smith
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,
Peter D.R. Rimm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
Indications for Use Statement
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: eSPIN
Indications for Use:
The eSPIN 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 1 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 (Per 21 C.F.R. 801.109) AND/OR
Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Long H. Chen -S 1300 700 1 1=1 300369056
(Division Sign-Off) Division of Surgical Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ K130057