HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBAR

K141557 · Gallini Medical Devices, Srl · HRX · Dec 8, 2014 · Orthopedic

Device Facts

• Record ID: K141557
• Device Name: HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBAR
• Applicant: Gallini Medical Devices, Srl
• Product Code: HRX · Orthopedic
• Decision Date: Dec 8, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Herniatome Percutaneous Discectomy Device is intended for use in aspiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine.

Device Story

The Herniatome Percutaneous Discectomy Device is a single-use, battery-powered probe used to remove intervertebral disc nucleus pulposus material. The device is operated under CT and fluoroscopic guidance. It features an internal double-pitch mechanism acting as a screw conveyor (augur style) to retrieve and remove excised debris through an outer cannula into a transparent collection container. The device is available in straight or curved distal end configurations with varying gauges and lengths for specific spinal regions. It is used by clinicians in a surgical or clinical setting. The device aids in the decompression of the disc, potentially relieving symptoms associated with disc-radiated conflict. The system includes an introducer needle for initial access.

Clinical Evidence

Bench testing only. No clinical or animal studies were conducted. Performance testing included accelerated aging, 3-year real-time shelf-life testing, battery life testing, electromagnetic compatibility (IEC 60601-1-2), electrical safety (IEC 60601-1), radiodetectability, and volume flow rate studies. Biocompatibility was verified per ISO 10993-1, including cytotoxicity, sensitization, intracutaneous reactivity, and acute systemic toxicity.

Technological Characteristics

Materials: Biocompatible stainless steel. Power: Battery-operated DC motor. Configuration: Straight or curved distal end cannula with lateral window; various gauges (17ga/20ga) and lengths (9cm/15cm/22cm). Sensing/Actuation: Mechanical augur-style screw conveyor. Sterilization: ISO 11135 compliant, SAL 10^-6. Connectivity: None. Software: None.

Indications for Use

Indicated for patients requiring aspiration of intervertebral disc nucleus pulposus material during percutaneous discectomy procedures in the lumbar, thoracic, and cervical spine regions.

Regulatory Classification

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.

Predicate Devices

• Stryker Instruments, Dekompressor™ Percutaneous Discectomy Probe (K032473)

Submission Summary (Full Text)

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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 image of a bird or abstract human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the image in a circular fashion.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 8, 2014

Gallini Medical Devices, Srl % Mr. Authur S. Goddard FDA Regulatory and Quality Systems Consultant 1531 Felton Road South Euclid, Ohio 44121

Re: K141557

Trade/Device Name: Herniatome Percutaneous Discectomy Device Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: November 4, 2014 Received: November 7, 2014

Dear Mr. Goddard:

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

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -S

- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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#### Section 4: Indication for Use Summary

510(k) Number (if known): _

Device Name:

#### Indications For Use:

The Herniatome Percutaneous Discectomy Device is intended for use in aspiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine.

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter-Use

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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The Summary of Safety and Effectiveness information on the Herniatome product is being submitted in accordance with the requirements of 21 C.F.R. §807.92 and reflects data available and represented at the time the submission was prepared, but caution should be execcised in interpreting the data. The results of future studies and or tests may require alterations of recommendations set forth.

#### SUBMITTER I.

| Applicant | Gallini Medical Devices, Srl<br>Via Frattini, 15<br>46100 Mantova, Italy |
|----------------|--------------------------------------------------------------------------|
| Telephone | [phone] |
| Facsimile | [phone] |
| Contact: | Duc H. Duong |
| Phone: | 888-361-6941 ext 122 |
| Email: | [e-mail] |
| Date Prepared: | June 6, 2014 |

#### II. DEVICE

| Name | Herniatome Percutaneous Discectomy Device |
|----------------------|-------------------------------------------|
| Common Name: | Percutaneous Discectomy Probe |
| Classification Name: | Arthroscope, 21 CFR 888.1100 |
| Regulatory Class: | Class II |
| Product Code: | HRX |

#### III. PREDICATE DEVICE

| Predicate: | Stryker Instruments, Dekompressor™ Percutaneous Discectomy Probe, K032473, market clearance date November 7, 2003. |
|------------|--------------------------------------------------------------------------------------------------------------------|
| | No reference devices were used in this submission. |

#### IV. DEVICE DESCRIPTION

| Description: | The Herniatome Percutaneous Discectomy Kit is comprised of an Introducer needle and a Herniatome Percutaneous Discectomy Device. The Herniatome Percutaneous Discectomy Device is a single-use disposable discectomy device that is designed to remove intervertebral disc nucleus pulpous material under CT and fluoroscopic guidance. Radiopaque marker bands are located on the Introducer needle and the Herniatome Percutaneous Discectomy Device. The Herniatome Percutaneous Discectomy Device contains a battery source DC motor that causes the internal double pitch mechanism to act as a screw conveyor to retrieve and remove the excised debris through the outer cannula and into the transparent collection container.<br><br>The Herniatome Percutaneous Discectomy Device is provided in two base models, a curved or straight distal end cannula with a lateral window and each model is provided with two different gage cannulas and two different cannula lengths for utilization in the specific region of the spine. |
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| Associated Accessories: | Introducer Needle |

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#### IV. DEVICE DESCRIPTION, continue

| Models: | Cervical Herniatome | | |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------|-----------------------------------------|
| | Product Code | Size | Description |
| | DS17-09 | 17ga – 9cm | Curved distal end with lateral window |
| | DS17-49 | 17ga – 9cm | Straight distal end with lateral window |
| | Lumbar Herniatome | | |
| | Product Code | Size | Description |
| | DS17-15 | 17ga – 15cm | Curved distal end with lateral window |
| | DS17-45 | 17ga – 15cm | Straight distal end with lateral window |
| Associated Accessories: | Introducer Needle | | |
| | Product Code | Size | Description |
| | DS 17/15 | 20 gage 22 cm | Introducer Needle |
| Sterilization: | The method used is based on practices recommended by ISO 11135 and<br>provides a Sterility Assurance Level (SAL) of 10-6 | | |

#### INDICATION FOR USE V.

| Intended Use: | The Herniatome Percutaneous Discectomy Device is intended for use in<br>aspiration of disc material during percutaneous discectomies in the lumbar,<br>thoracic, and cervical regions of the spine. |
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#### VI. COMPARISION OF TECHNOLOGICAL CHARACTERISTIC WITH PREDICATE DEVICE

| Substantial Equivalency<br>Information: | Percutaneous discectomy is the technological principle for both the subject<br>and predicate device. Discography is performed to confirm the targeted disc-<br>radiated conflict. A cannula and stylet are guided into the target disc under CT<br>and fluoroscopic guidance. The stylet is removed and the Herniatome is<br>advanced into the targeted disc-radiated conflict. Once activated the<br>Herniatome is used to aspirate the disc material in the lumbar, thoracic, and<br>cervical regions of the spine. The Herniatome and predicate device are based<br>on the following technological elements:<br><br>• Single-use disposable discectomy device<br>• Target Anatomy: Cervical, thoracic and lumbar spinal segments<br>• Configuration: Straight and curved<br>• Power: DC motor<br>• Mechanic of Action: Augur style mechanism to retrieve and remove<br>the excised matter<br>• Patient contact material: biocompatible stainless steel |
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### VII. PERFORMACE DATA

| Biocompatibility: | The Herniatome Percutaneous Discectomy Device produced by Gallini<br>Medical Products was assessed against the International Standard ISO 10993-<br>1, "Biological evaluation of medical devices. Part 1. Guidance on selection of tests." The<br>Herniatome would be classified as an External Communicating Device in<br>contact with Tissue/Bone/Dentin Communicating for a Limited Duration (<24 hours). The battery of testing include the following tests:<br>Test Standard Cytotoxicity ISO 10993-5 Maximum Sensitization – sodium chloride ISO 10993-10 Maximum Sensitization – sesame oil ISO 10993-10 Intracutaneous Reactivity ISO 10993-10 Acute Systemic Toxicity ISO 10993-11 | | | | | | | | | | | | |
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| Electrical Safety and<br>Electromagnetic<br>Compatibility: | Electrical Safety and Electromagnetic Compatibility that were performed on<br>the Herniatome Percutaneous Discectomy Device in accordance with IEC<br>60601-1 standards for safety and the IEC 60601-1-2. Standard for<br>Electromagnetic Compatibility. | | | | | | | | | | | | |
| Performance Testing: | The Herniatome Percutaneous Discectomy Device successfully passed all of<br>the following performance tests:<br>Herniatome Percutaneous Discectomy Device Performance<br>Testing Accelerated Aging Shelf Life Package Testing 3-year Real Time Aging Battery Life Testing Electromagnetic Compatibility and Electrical Safety Radiodetectability Technical Characteristic Performance Volume Flow Rate Study | | | | | | | | | | | | |
| Shelf Life: | In accordance with ISO 11607 the real time three year aging of Herniatome<br>Percutaneous Discectomy Device demonstrated that the performance of the<br>device met the standard requirements without any significant difference to<br>product performance requirements before aging. So the product is stable and<br>reliable within the three-year useful life. | | | | | | | | | | | | |
| Software Verification<br>and Validation Testing: | The Herniatome Discectomy Device does not contain any software. | | | | | | | | | | | | |
| Animal Studies: | The Herniatome Percutaneous Discectomy Device did not conduct any<br>performance testing on animals. | | | | | | | | | | | | |

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### VII. CONCLUSION

| Conclusion: | The information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the Herniatome Percutaneous Discectomy Kit supports a determination of substantially equivalent to existing legally marketed predicate device DekompressorTM Percutaneous Discectomy Probe, K032473. Any technological differences between the Herniatome Percutaneous Discectomy Kit and the predicate Stryker Instruments, DekompressorTM Percutaneous Discectomy Probe, K032473 System device do not raise new questions of safety or effectiveness. |
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