(179 days)
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.
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.
This document describes a 510(k) premarket notification for the "Herniatome Percutaneous Discectomy Device". The purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device. This is NOT a study about an AI/ML device, and therefore several of your requested categories (1, 2, 3, 4, 5, 6, 7, 8, 9) are not applicable as they relate to AI/ML device performance and testing.
Here's the relevant information that can be extracted from the provided text regarding the device and its performance testing:
Device Name: Herniatome Percutaneous Discectomy Device
Predicate Device: Stryker Instruments, Dekompressor™ Percutaneous Discectomy Probe, K032473
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.
1. Table of acceptance criteria and the reported device performance
The document does not provide a table of explicit numeric acceptance criteria for the performance tests, nor does it report specific numerical device performance metrics. Instead, it states that the device "successfully passed all of the following performance tests."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Device classified as an External Communicating Device in contact with Tissue/Bone/Dentin Communicating for a Limited Duration (<24 hours). Tests performed include Cytotoxicity, Maximum Sensitization (sodium chloride & sesame oil), Intracutaneous Reactivity, and Acute Systemic Toxicity, all assessed against ISO 10993-1, 10993-5, 10993-10, and 10993-11. | "produced by Gallini Medical Products was assessed against the International Standard ISO 10993-1… The battery of testing include the following tests… [all tests listed in Acceptance Criteria column]." (Implied success as no failure is reported, and a substantial equivalence claim is made.) |
| Electrical Safety and Electromagnetic Compatibility: Compliance with IEC 60601-1 standards for safety and IEC 60601-1-2 for Electromagnetic Compatibility. | "Electrical Safety and Electromagnetic Compatibility that were performed on the Herniatome Percutaneous Discectomy Device in accordance with IEC 60601-1 standards for safety and the IEC 60601-1-2. Standard for Electromagnetic Compatibility." (Implied success as no failure is reported, and a substantial equivalence claim is made.) |
| Performance Testing: (Specific criteria not detailed, but tests included: 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) | "The Herniatome Percutaneous Discectomy Device successfully passed all of the following performance tests." |
| Shelf Life: Performance of the device meets standard requirements without significant difference to product performance requirements before aging, demonstrating stability and reliability within a three-year useful life, in accordance with ISO 11607. | "In accordance with ISO 11607 the real time three year aging of Herniatome Percutaneous Discectomy Device demonstrated that the performance of the device met the standard requirements without any significant difference to product performance requirements before aging. So the product is stable and reliable within the three-year useful life." |
| Software Verification and Validation Testing: (Applicable if device contains software) | "The Herniatome Discectomy Device does not contain any software." (No software present, thus no V&V testing required.) |
| Animal Studies: (Applicable if device conducts performance testing on animals) | "The Herniatome Percutaneous Discectomy Device did not conduct any performance testing on animals." (No animal studies conducted.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document lists performance tests conducted but does not detail sample sizes, data provenance (e.g., 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 (e.g. radiologist with 10 years of experience)
This is not applicable as it is a medical device submission, not specifically an AI/ML device performance study requiring expert ground truth for classification/detection tasks. The "ground truth" for this device would be its ability to physically perform its intended function, as demonstrated by engineering and biocompatibility tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for this type of medical device submission. Adjudication methods are typically associated with human-in-the-loop studies or clinical trials involving subjective assessments, which are not detailed here.
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
21 CFR 888.1100 (Arthroscope) is not an AI/ML device. Therefore, a multi-reader multi-case comparative effectiveness study with AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The Herniatome Percutaneous Discectomy Device is a mechanical surgical instrument, not an algorithm or AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, "ground truth" is established through engineering principles, material science, and adherence to performance standards and regulations.
- Biocompatibility: Demonstrated through validated laboratory tests (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity) against ISO standards.
- Electrical Safety & EMC: Demonstrated through testing against IEC standards.
- Performance (e.g., Volume Flow Rate, Radiodetectability): Demonstrated through specific engineering tests, where the "ground truth" is the established functional specification or expected physical behavior under test conditions.
- Shelf Life: Demonstrated through accelerated and real-time aging studies, ensuring the device maintains its performance and sterility over time, according to ISO 11607.
There is no "expert consensus" or "pathology" in the sense of diagnostic interpretation for this mechanical device's ground truth.
8. The sample size for the training set
This is not applicable as the device is not an AI/ML system that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as the device is not an AI/ML system that requires a training set or associated ground truth.
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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 (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, SrlVia Frattini, 1546100 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 andprovides a Sterility Assurance Level (SAL) of 10-6 |
INDICATION FOR USE V.
| Intended Use: | The Herniatome Percutaneous Discectomy Device is intended for use inaspiration 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 EquivalencyInformation: | Percutaneous discectomy is the technological principle for both the subjectand predicate device. Discography is performed to confirm the targeted disc-radiated conflict. A cannula and stylet are guided into the target disc under CTand fluoroscopic guidance. The stylet is removed and the Herniatome isadvanced into the targeted disc-radiated conflict. Once activated theHerniatome is used to aspirate the disc material in the lumbar, thoracic, andcervical regions of the spine. The Herniatome and predicate device are basedon 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 removethe excised matter• Patient contact material: biocompatible stainless steel |
|---|---|
| ----------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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VII. PERFORMACE DATA
| Biocompatibility: | The Herniatome Percutaneous Discectomy Device produced by GalliniMedical Products was assessed against the International Standard ISO 10993-1, "Biological evaluation of medical devices. Part 1. Guidance on selection of tests." TheHerniatome would be classified as an External Communicating Device incontact with Tissue/Bone/Dentin Communicating for a Limited Duration (<24 hours). The battery of testing include the following tests: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 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Electrical Safety andElectromagneticCompatibility: | Electrical Safety and Electromagnetic Compatibility that were performed onthe Herniatome Percutaneous Discectomy Device in accordance with IEC60601-1 standards for safety and the IEC 60601-1-2. Standard forElectromagnetic Compatibility. | ||||||||||||
| Performance Testing: | The Herniatome Percutaneous Discectomy Device successfully passed all ofthe following performance tests:Herniatome Percutaneous Discectomy Device PerformanceTesting 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 HerniatomePercutaneous Discectomy Device demonstrated that the performance of thedevice met the standard requirements without any significant difference toproduct performance requirements before aging. So the product is stable andreliable within the three-year useful life. | ||||||||||||
| Software Verificationand Validation Testing: | The Herniatome Discectomy Device does not contain any software. | ||||||||||||
| Animal Studies: | The Herniatome Percutaneous Discectomy Device did not conduct anyperformance 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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§ 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.