(347 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, sterilization, shelf life, biocompatibility, electrical safety, and tissue removal performance of a radiofrequency electrode device. There is no mention of AI, ML, image processing, or any data-driven algorithms.
Yes
The device is indicated for ablation and decompression of disc material to treat symptomatic patients with contained herniated discs. These are therapeutic actions aimed at alleviating symptoms and treating a medical condition.
No
The device description clearly states its intended use is for ablation, decompression, removal, or coagulation of disc material, which are therapeutic interventions, not diagnostic ones.
No
The device description clearly outlines a physical RF electrode device made of stainless steel shafts and polyamide coating, intended for percutaneous surgical procedures. It is a hardware device, not software.
Based on the provided information, the SPINUAT-P is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "ablation, and decompression of disc material to treat symptomatic patients with contained herniated discs." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a "minimally invasive RF electrode device" used for "percutaneous disc decompression surgery." It is designed to be placed into the epidural space or disc to remove, ablate, or coagulate disc material. This is a surgical tool.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The SPINUAT-P does not interact with or analyze such specimens.
The SPINUAT-P is a surgical device used for a therapeutic intervention, not a diagnostic test performed on in vitro samples.
N/A
Intended Use / Indications for Use
The SPINUAT-P is indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The SPINAUT-P is a minimally invasive RF electrode device offered in 496mm length for percutaneous disc decompression surgery using radiofrequency energy and designed for use with radiofrequency generators in RF procedure. SPINAUT-P is intended to be placed into the epidural space or posterolateral / posterocentral area in the disc to remove, ablate or coagulate disc material in the area. The electrode consists of two stainless steel shafts with straight electrode configuration design. The shaft is housed in a coating composed of Polyamide. The device is single-use gamma radiation sterilized and is compatible with most standard electrosurgical generators that provide a cable with two pin outlet (2-pin, 22mm) with 1kVp maximum electrical capacity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
disc (specifically referring to contained herniated discs)
epidural space
posterolateral / posterocentral area in the disc
Indicated Patient Age Range
Not Found
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)
Non-Clinical Testing:
- Sterilization validating testing has been performed in accordance with ISO 11137-1, 2, 3 and ISO 11737-1, 2, 3, and the test results met the pre-set criteria.
- The tests to validate the shelf life of the device through the proposed shelf life were conducted using the accelerated aging method in accordance to ASTM F1980-07 and the test results validated 3 year shelf life.
- The following biocompatibility tests were performed in accordance with ISO 10993-4, 5, 10, 11 and USP 37 , and the test results supported that the subject device is biocompatible.
- The following electrical safety and bench tests were performed to evaluate the performance and the safety of the subject device and the test results met the pre-set criteria.
- Performance Comparison Test: We compared the tissue removal, durability, and ability to navigation in the lesion (performance to be introduced, directed to and extracted from the target lesion) of our RF Electrode SPINAUT-P and the predicate device, L'disQby U and I (K132797) using porcine spines. The test results demonstrated the device being as safe and as effective as the predicate device.
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines extending from their necks. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 18, 2016
IMEDICOM Co., Ltd. c/o Ms. Priscilla Chung LK Consulting Group USA, Inc. 2651 E. Chapman Ave., Ste. 110 Fullerton, CA 92831
Re: K150915
Trade/Device Name: SPINAUT-P Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessoriesv Regulatory Class: Class II Product Code: GEI Dated: February 24, 2016 Received: February 26, 2016
Dear Ms. Chung:
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 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
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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.
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150915
Device Name
SPINAUT-P
Indications for Use (Describe)
The SPINUAT-P is indicated for ablation, and decompression of disc material to treat symptomatic patients with contained herniated discs.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
(K150915)
This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: Mar 17, 2016
1. Applicant / Submitter
IMEDICOM Co., Ltd. #612, 172, LS-ro, Gunpo-si, Gyeonggi-do, 435-824 Republic of Korea Tel:+82-31-479-1156 Fax:+82-31-479-1157
2. Submission Correspondent
LK Consulting Group USA, Inc. 2651 E Chapman Ave. Ste 110, Fullerton CA 92831 Priscilla Chung Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device
- I Trade Name: SPINAUT-P
- י Common Name: Electrosurgical accessory
- " Classification Name: Electrosurgical cutting and coagulation device and accessories
- י Product Code: GEI
- י Classification regulation: 21 CFR 878.4400
4. Predicate Device:
- ArthroCare® Coblator IQ™ Perc-D®, SpineWand® (Coblator IQ DLR and DLG י SpineWands) by Arthrocare Corp. (K132099)
- L'DISQ by U&I Corporation (K132797) י
5. Description:
The SPINAUT-P is a minimally invasive RF electrode device offered in 496mm length for percutaneous disc decompression surgery using radiofrequency energy and designed
4
for use with radiofrequency generators in RF procedure. SPINAUT-P is intended to be placed into the epidural space or posterolateral / posterocentral area in the disc to remove, ablate or coagulate disc material in the area. The electrode consists of two stainless steel shafts with straight electrode configuration design. The shaft is housed in a coating composed of Polyamide. The device is single-use gamma radiation sterilized and is compatible with most standard electrosurgical generators that provide a cable with two pin outlet (2-pin, 22mm) with 1kVp maximum electrical capacity.
6. Indication for use:
The SPINUAT-P is indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs.
7. Basis for Substantial Equivalence
The subject device is the same as the predicate device in the indications for use, materials, energy source, performance specifications, electrode thickness, mode of operation (bipolar) and sterilization method. The major difference is the electrode length but this difference does not raise a question of safety and performance since the electrode is coated with the polyamid to protect the patient and the user from electrical leakage and burn. In this regard, the longer electrode does not raise a question of safety issue. The electrode length would not be a performance affecting factor either since the thickness of the tip would matter the most which is the only part exposed to the patient. The performance test results submitted in this 510K submission also supports that the subject device is substantially equivalent to the predicate devices despite this difference.
| Trade name | SPINAUT-P | ArthroCare®
Coblator IQ™ Perc-
D®
SpineWand®
(Coblator IQ DLR
and DLG
SpineWands) | L'DISQ | |
|------------------|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacture | IMEDICOM Co., Ltd. | Arthrocare Corp. | U&I Corporation | |
| 510(k) number | - | K132099 | K132797 | |
| Product Code | GEI | GEI | GEI | |
| | Indications for Use | The SPINUAT-P is indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs. | The ArthroCare Coblator IQ Perc-D Spine Wands (Coblator IQ DLR and Coblator IQ DLG SpineWands) are indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated lumbar and lumbosacral discs. The Wands are designed to be used exclusively with the ArthroCarc Coblator IQ Controller. | The L'DISQ is indicated for coagulation and ablation of disc material to treat symptomatic patients with contained herniated discs. |
| | Principle of Operation | Electrode is activated using the generator which starts the coblation process to ablate disc tissue. The coblation process involves use of a conductive media to create a plasma layer to ablate tissue. | Electrode is activated using the generator which starts the coblation process to ablate disc tissue. The coblation process involves use of a conductive media to create a plasma layer to ablate tissue. | Electrode is activated using the generator which starts the coblation process to ablate disc tissue. The coblation process involves use of a conductive media to create a plasma layer to ablate tissue. |
| Material | Electrode | Stainless Steel 304 | Stainless Steel 304 | Stainless Steel 304 |
| | Handle | Polyamide | Polyamide | Polyamide |
| Perfor-
mance | RF leakage current | ≤7.2 dfL mA | ≤7.2dfL mA | ≤7.2dfL mA |
| Size | Electrode length | 496.0 mm | 300.0350.0mm | 210.0mm |1.0mm | 0.7mm
| | Electrode thickness | 1.0 mm | 0.8
1.0mm |
| | Compatibility w/other devices | Standard RF generator | with the ArthroCare Coblator IQ Controller | Standard RF Generator |
| | Chemical Safety | Biocompatible | Biocompatible | Biocompatible |
5
6
- dfL
d : the cable's smallest external dimension(unit : mm)
f : test frequency(unit : MHz)
L : length of cable submerged in saline solution
8. Non-Clinical Testing
- · Sterilization validating testing has been performed in accordance with ISO 11137-1, 2, 3 and ISO 11737-1, 2, 3, and the test results met the pre-set criteria.
- · The tests to validate the shelf life of the device through the proposed shelf life were conducted using the accelerated aging method in accordance to ASTM F1980-07 and the test results validated 3 year shelf life.
| No. | Test | Test Description / Referenced Standard |
|---|---|---|
| 1 | Appearance | Visual Inspection |
| 2 | Electrical Conductivity Test | Connect an electric circuit meter to the |
| device and check electrical conductivity | ||
| by electric circuit tester. | ||
| 3 | Tensile Strength Test of Electrode | |
| Cord | Test in accordance with ANSI/AAMI | |
| HF18:2001 Electrosurgical devices | ||
| Clause 4.2.5.5 | ||
| 4 | Package Tensile Test | Test in accordance with ASTM D882-12, |
| standard test methods for tensile | ||
| properties of thin plastic sheeting. | ||
| (Ophthalmic) | ||
| 5 | Package Peeling Test | Test in accordance with ASTM |
| F88/F88M-09, standard test method for | ||
| seal strength of flexible barrier materials. | ||
| (Sterility) | ||
| б | Package Dye Penetration Test | Test in accordance with ASTM F1929-12, |
| standard test method for detecting seal | ||
| leaks in porous medical packaging by dye | ||
| penetration. (Sterility) | ||
| 7 | Sterility Test | Test in accordance with ISO 11737-2 |
| Second edition 2009-11-15, sterilization | ||
| of medical devices - microbiological | ||
| methods - part 2: tests of sterility | ||
| performed in the definition, validation and | ||
| maintenance of a sterilization process. | ||
| (Sterility) |
7
- · The following biocompatibility tests were performed in accordance with ISO 10993-4, 5, 10, 11 and USP 37 , and the test results supported that the subject device is biocompatible.
| No. | Test | Test Description / Referenced Standards |
|---|---|---|
| 1 | Extraction Test | |
| 2 | Cytotoxicity | ISO 10993-5:2009/(R) 2014, biological |
| evaluation of medical devices -- part 5: | ||
| tests for in vitro cytotoxicity. | ||
| (Biocompatibility) | ||
| 3 | Skin Sensitization | ISO 10993-10 Third Edition 2010-08-01, |
| biological evaluation of medical devices - | ||
| part 10: tests for irritation and skin | ||
| sensitization. (Biocompatibility) | ||
| 4 | Intracutaneous reactivity | ISO 10993-10 Third Edition 2010-08-01, |
| biological evaluation of medical devices - | ||
| part 10: tests for irritation and skin | ||
| sensitization. (Biocompatibility) | ||
| 5 | Acute Systemic Toxicity Test | ISO 10993-11 Second edition 2006-08-15, |
| biological evaluation of medical devices | ||
| part 11: tests for systemic toxicity. | ||
| (Biocompatibility) | ||
| 6 | Pyrogen | USP 37-NF32:2014, pyrogen test |
| (usp rabbit test). (Sterility) | ||
| 7 | Haemolysis | ISO 10993-4:2002 Biological evaluation of |
| medical devices -- Part 4: Selection of tests | ||
| for interactions with blood |
- The following electrical safety and bench tests were performed to evaluate the performance and the safety of the subject device and the test results met the pre-set criteria.
| No. | Test | Test Description / Referenced Standards |
|---|---|---|
| 1 | Electrical Conductivity Test | Evaluate if the electrode is able to pass |
| electricity. | ||
| 2 | Cable Dielectric Strength Test | IEC 60601-2-2 Edition 5.0 2009-02, |
| medical electrical equipment - part 2-2: | ||
| particular requirements for the basic safety | ||
| and essential performance of high | ||
| frequency surgical equipment and high | ||
| frequency surgical accessories [including: | ||
| technical corrigendum 1 (2014)]. (General | ||
| Plastic Surgery/General Hospital) |
8
| | | • Clause 201.8.8.3.104 Line voltage
withstanding capability
• Clause 201.8.8.3.103 High frequency
voltage withstanding capability |
|---|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| 3 | High Frequency Leakage Test of
Electrode | Test in accordance with ANSI/AAMI HF
18:2001 Electrosurgical Devices
• Clause 4.2.5.2 |
| 4 | Appearance | Visual Inspection |
| 5 | Size Measurement | Measure the size of the test article by
vernier calipers. |
| 6 | Tensile Strength Test of
Electrode Cord | Test in accordance with ANSI/AAMI HF
18:2001 Electrosurgical Devices
• Clause 4.2.5.5 |
| 7 | Sterility test | Korean Pharmacopeia (10th Edition) :
General Requirements for Tests and
Assays / Sterility Test |
- 〈We compared the tissue removal, durability, and ability to navigation in the lesion (performance to be introduced, directed to and extracted from the target lesion) of our RF Electrode SPINAUT-P and the predicate device, L'disQby U and I (K132797) using porcine spines. The test results demonstrated the device being as safe and as effective as the predicate device.
| No. | Test | Test Description |
|---|---|---|
| 1 | Performance Comparison Test with the | |
| predicate device using porcine spines | • Tissue Removal Performance | |
| • Durability of Electrode | ||
| • Ability to be introduced, directed | ||
| to and extracted from the surgical | ||
| site(target area) |
All the test results supported that the subject device is substantially equivalent to the predicate devices.
9. Conclusion
Based on the similarities, we conclude that the SPINAUT-P is substantially equivalent to the predicate devices.