(179 days)
No reference devices were used in this submission.
No
The summary explicitly states "The device does not contain any software." and there are no mentions of AI, ML, or related concepts.
Yes
The device is intended for "aspiration of disc material during percutaneous discectomies," which is a procedure designed to treat a medical condition.
No
The device is described as a "Percutaneous Discectomy Device" intended for "aspiration of disc material," "designed to remove intervertebral disc nucleus pulposus material." This indicates a therapeutic, not diagnostic, function.
No
The device description explicitly states that the device contains a battery source DC motor and is a single-use disposable discectomy device with physical components like needles and cannulas. Furthermore, the performance studies section explicitly states, "The device does not contain any software."
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring or compatibility purposes.
- Device Function: The Herniatome Percutaneous Discectomy Device is designed to physically remove disc material from the spine during a surgical procedure. It is an invasive surgical device, not a device that analyzes biological samples outside of the body.
- Intended Use: The intended use clearly states "aspiration of disc material during percutaneous discectomies," which is a surgical intervention.
- Device Description: The description details a mechanical device with a motor and cannula for removing tissue, not a system for analyzing biological samples.
Therefore, based on the provided information, the Herniatome Percutaneous Discectomy Device is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HRX
Device 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT and fluoroscopic guidance
Anatomical Site
lumbar, thoracic, and cervical regions of the spine
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)
Biocompatibility:
The Herniatome Percutaneous Discectomy Device produced by Gallini Medical Products was assessed against the International Standard ISO 10993-1, "Biological evaluation of medical devices. Part 1. Guidance on selection of tests." The Herniatome would be classified as an External Communicating Device in contact with Tissue/Bone/Dentin Communicating for a Limited Duration (
§ 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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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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
Via Frattini, 15
46100 Mantova, Italy |
|----------------|--------------------------------------------------------------------------|
| Telephone | +39 0376 322038 |
| Facsimile | +39 0376 327922 |
| Contact: | Duc H. Duong |
| Phone: | 888-361-6941 ext 122 |
| Email: | d.duong@gallinimedical.com |
| 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.
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. |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | ||
| 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
aspiration of disc material during percutaneous discectomies in the lumbar,
thoracic, and cervical regions of the spine. |
| --------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
VI. COMPARISION OF TECHNOLOGICAL CHARACTERISTIC WITH PREDICATE DEVICE
| Substantial Equivalency
Information: | Percutaneous discectomy is the technological principle for both the subject
and predicate device. Discography is performed to confirm the targeted disc-
radiated conflict. A cannula and stylet are guided into the target disc under CT
and fluoroscopic guidance. The stylet is removed and the Herniatome is
advanced into the targeted disc-radiated conflict. Once activated the
Herniatome is used to aspirate the disc material in the lumbar, thoracic, and
cervical regions of the spine. The Herniatome and predicate device are based
on the following technological elements:
• Single-use disposable discectomy device
• Target Anatomy: Cervical, thoracic and lumbar spinal segments
• Configuration: Straight and curved
• Power: DC motor
• Mechanic of Action: Augur style mechanism to retrieve and remove
the excised matter
• Patient contact material: biocompatible stainless steel |
| ----------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
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VII. PERFORMACE DATA
| Biocompatibility: | The Herniatome Percutaneous Discectomy Device produced by Gallini
Medical Products was assessed against the International Standard ISO 10993-
1, "Biological evaluation of medical devices. Part 1. Guidance on selection of tests." The
Herniatome would be classified as an External Communicating Device in
contact with Tissue/Bone/Dentin Communicating for a Limited Duration (