(161 days)
The Matreneu® Percutaneous Balloon Compression Kit is intended to the Percutaneous Balloon Compression (PBC) procedure for primary trigeminal neuralgia.
The Matreneu® Percutaneous Balloon Compression Kit is intended to be used to the Percutaneous Balloon Compression (PBC) procedure for primary trigeminal neuralgia.
The subject device consist of five parts, such as the balloon catheter, puncture needle, svringe, connector, and pressure gauge. Through a sheath under X-ray fluoroscopy. a micro-balloon is introduced into the meniscus of the trigeminal nerve in Meckel's cavity to assist in retraction and establishment of a pathway. Then inject the contrast agent to fill the balloon to relieve the compression of the nerve fibers that cause trigeminal neuralgia. And through the expansion of the micro-balloon compression injury to treat trigeminal neuralgia.
The Kit is supplied sterile and is intended for single use.
The provided text is a 510(k) summary for the Matreneu® Percutaneous Balloon Compression Kit. It outlines the device's intended use and compares it to a predicate device, but it does not include information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/ML powered device.
The document states: "No clinical tests were performed." and primarily focuses on non-clinical performance testing related to physical and chemical properties, sterilization, shelf-life, and biocompatibility.
Therefore, many of the requested details, particularly those related to AI/ML powered device evaluation, are not present in the provided text.
Here is an attempt to answer the questions based only on the information provided, with many entries indicating that the information is not available:
Acceptance Criteria and Device Performance Study for Matreneu® Percutaneous Balloon Compression Kit
This document, a 510(k) summary, primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe acceptance criteria in the context of clinical performance or a study proving the device meets these criteria for an AI/ML powered device. The device described, Matreneu® Percutaneous Balloon Compression Kit, is a non-powered surgical instrument, not an AI/ML driven one.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria Description | Reported Device Performance and Study Findings |
|---|---|---|
| For AI/ML Powered Device | Not Applicable: The Matreneu® Percutaneous Balloon Compression Kit is a non-powered neurosurgical instrument and not an AI/ML powered device. Therefore, no acceptance criteria or performance metrics related to AI/ML (e.g., sensitivity, specificity, AUC) are discussed in this document. | |
| Non-Clinical Testing | ETO Residuals: Meet criteria defined in ISO 11135 Second edition 2014 and ISO 10993-7:2008. | Passed: EO residual was measured and met the specified criteria. |
| Shelf-Life: Maintain essential performance for three years, meeting ISO 11607-1:2006 requirements. | Passed: Shelf-life for three years "had been validated in real-time aging test" and met packaging requirements. Essential performance achieved before and after shelf-life test. | |
| Biocompatibility: Demonstrated in accordance with 2020 FDA Guidance document Use of International Standard ISO-10993-1. | Passed: Cytotoxicity, sensitization, intracutaneous irritation, system toxicity, In Vitro Hemolytic Properties Test, and pyrogen tests were performed to demonstrate biocompatibility. | |
| Electromagnetic Compatibility (EMC) & Electrical Safety: Meet requirements per AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-1-2 Edition 3: 2007-03. | Passed: Tests on Electromagnetic Compatibility and Electrical Safety were performed in accordance with the cited requirements. | |
| Clinical Performance | Not specified as clinical tests were not performed. | Not performed: The document explicitly states: "No clinical tests were performed." |
Note: The "acceptance criteria" here are inferred from the non-clinical tests conducted to support the marketing claims and confirm safety and effectiveness equivalent to the predicate device. They are primarily engineering and material performance specifications rather than diagnostic or treatment efficacy metrics typically associated with AI/ML systems.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable: No test set in the context of an AI/ML algorithm is mentioned or implied, as the device is a physical, non-powered surgical instrument. The non-clinical tests used samples of the device itself (e.g., for EO residuals, aging, biocompatibility tests). The number of such samples is not specified.
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)
- Not applicable: No expert-established ground truth for an AI/ML algorithm's test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable: No test set for an AI/ML algorithm requiring adjudication is mentioned.
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
- No: The document states, "No clinical tests were performed." Furthermore, this device is a physical instrument, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No: This device is a physical instrument. There is no algorithm mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable: No ground truth in the context of an AI/ML algorithm is mentioned. For the non-clinical tests, the "ground truth" would be established by the standards themselves (e.g., ISO 11135 for EO residuals, ISO-10993-1 for biocompatibility).
8. The sample size for the training set
- Not applicable: No training set for an AI/ML algorithm is mentioned.
9. How the ground truth for the training set was established
- Not applicable: No training set or associated ground truth establishment is mentioned for this device.
{0}------------------------------------------------
September 7, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue.
Shenzhen Shineyard Medical Device Co. Ltd. % Joyce Yang Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square Nanshan District Shenzhen, Guangdong 518100 China
Re: K220920
Trade/Device Name: Matreneu Percutaneous Balloon Compression Kit Regulation Number: 21 CFR 882.4535 Regulation Name: Nonpowered Neurosurgical Instrument Regulatory Class: Class I Product Code: HAO Dated: August 8, 2022 Received: August 8, 2022
Dear Joyce Yang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
{1}------------------------------------------------
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Adam Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K220920
Device Name
Matreneu Percutaneous Balloon Compression Kit
Indications for Use (Describe)
The Matreneu Percutaneous Balloon Compression Kit is intended to the Percutaneous Balloon Compression (PBC) procedure for primary trigeminal neuralgia.
| Type of Use (Select one or both, as applicable) |
|---|
| For Therapeutic Use in an OTP or Other Setting For Take-Home Use (if allowed by OTP's accreditation) |
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary
Date of Summary prepared: September 7, 2022
1. Submission Sponsor
| Applicant Name | Shenzhen Shineyard Medical Device Co. Ltd. |
|---|---|
| Address | 3F, Changfeng Industrial Block No.3 Liuxian Road,Xin'an Bao'an District, Shenzhen, Guangdong,518000, China. |
| Contact person | Yan Ping |
| Phone | +86-755-26912231 |
Submission correspondent 2.
| Name | Shenzhen Joyantech Consulting Co., Ltd |
|---|---|
| Address | 1713A, 17th Floor, Block A, Zhongguan TimesSquare, Nanshan District, Shenzhen |
| Post Code | 518000 |
| Phone No. | +86-755-86069197 |
| Contact Person | Joyce Yang |
| joyce@cefda.com |
Device Identification 3.
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade Name: | Matreneu® Percutaneous Balloon Compression Kit |
| Classification name: | Instrument, Surgical, Non-Powered |
| Review Panel: | Neurology |
| Product Code: | HAO |
| Device Class: | 1 |
| Regulation Number: | 21 CFR § 882.4535 |
Legally Marketed Predicate Device 4.
| Trade Name | MULLAN GANGLION MICROCOMPRESSIONSET |
|---|---|
| Regulation number | 21 CFR § 882.4535 |
| Regulation class | 1 |
| Regulation name | Nonpowered neurosurgical instrument |
| 510(k) Number | K940973 |
| Product Code | HAO |
| Manufacturer | COOK Incorporated |
{4}------------------------------------------------
Device Description 5.
The Matreneu® Percutaneous Balloon Compression Kit is intended to be used to the Percutaneous Balloon Compression (PBC) procedure for primary trigeminal neuralgia.
The subject device consist of five parts, such as the balloon catheter, puncture needle, svringe, connector, and pressure gauge. Through a sheath under X-ray fluoroscopy. a micro-balloon is introduced into the meniscus of the trigeminal nerve in Meckel's cavity to assist in retraction and establishment of a pathway. Then inject the contrast agent to fill the balloon to relieve the compression of the nerve fibers that cause trigeminal neuralgia. And through the expansion of the micro-balloon compression injury to treat trigeminal neuralgia.
The Kit is supplied sterile and is intended for single use.
6. Intended Use/ Indications for Use
The Matreneu® Percutaneous Balloon Compression Kit is intended to the Percutaneous Balloon Compression (PBC) procedure for primary trigeminal neuralgia.
| Comparisonitem | Subject Device: Matreneu®Percutaneous BalloonCompression Kit | Predicate Device: MULLANGANGLIONMICROCOMPRESSIONSET(K940973) | Comments |
|---|---|---|---|
| ProductCode | HAO | HAO | Same |
| RegulationNumber | 21 CFR § 882.4535 | 21 CFR § 882.4535 | Same |
| Classification | Class I | Class I | Same |
| Type of use | Prescription Use | Prescription Use | Same |
| Intendeduse &Indications for Use | The MatreneuPercutaneous BalloonCompression Kit isintended to be used to thePercutaneous BalloonCompression (PBC)procedure for primarytrigeminal neuralgia. | The Mullan PercutaneousTrigeminal GanglionMicrocompression Set isintended for use in thepercutaneous treatment oftrigeminal neuralgia. Thisset is supplied sterile in apeel - open package and isintended for one - time use. | Same |
| Applicableuser | The subject device isindicated for patients withtrigeminal neuralgia treatedby compression | The subject device isindicated for patients withtrigeminal neuralgia treatedby compression | Same |
| Comparisonitem | Subject Device: Matreneu®Percutaneous BalloonCompression Kit | Predicate Device: MULLANGANGLIONMICROCOMPRESSIONSET(K940973) | Comments |
| neurosurgery. | neurosurgery. | ||
| Environmentof use | The subject deviceexpected to be used in asterile operating room. | The subject deviceexpected to be used in asterile operating room. | Same |
| Single/repeat use | Single use | Single use | Same |
| Sterile /non-sterile | Marketed as a sterile device | Marketed as a sterile device | Same |
| Sterilizationmethod andSAL | ETO sterileSAL=10-6 | ETO sterileSAL=10-6 | Same |
| Components | Balloon catheterPuncture needleSyringeConnectorPressure gauge | Microcompression BalloonCatheterNeedle with styletSyringeScalpelNeedleAngled needle gaugeGauze padAdhesive bandage | Different(Issue 1) |
| Workingprinciple | Through a sheath under X-ray fluoroscopy, a micro-balloon is introduced intothe meniscus of thetrigeminal nerve inMeckel's cavity to assist inretraction andestablishment of apathway. Then slowly injectthe contrast agent to fill the | Through a sheath under X-ray fluoroscopy, a micro-balloon is introduced intothe meniscus of thetrigeminal nerve inMeckel's cavity to assist inretraction andestablishment of apathway. Then slowly injectthe contrast agent to fill theballoon to relieve thecompression of the nervefibers that cause trigeminalneuralgia. And through theexpansion of the micro-balloon compression injury,so as to treat trigeminalneuralgia. | Same |
7. Technological characteristics comparison
{5}------------------------------------------------
Issue 1: The components of the subject device are not exactly the same as the predicate device. Compared with the predicate device, the subject device contains the same key components as the predicate device, such as Balloon Catheter, Puncture needle, and Syringe. The difference is that the predicate device contains some accessories, such as Scalpel, Angled needle gauge,
{6}------------------------------------------------
Gauze pad and Adhesive bandage. However, these accessories do not affect the intended use, performance and clinical operation of the device. In addition, the subject device includes connector and pressure gauge. The connector is used to connect the balloon catheter to the pressure gauge. The pressure gauge is only used to show the injection pressure, not to determine the amount of contrast agent to be injected. The connector and the pressure gauge also do not affect the intended use and performance of the device. Therefore, the differences dot not raise new risk of safety and effectiveness.
8. Summary of non-clinical testing
Performance testing was conducted on physical and chemical properties to support the marketing claims and to confirm that the safety and effectiveness of the Matreneu® Percutaneous Balloon Compression Kit is at least equivalent to the predicate device.
The EO residual was measured after sterilization of the device to meet the criteria defined in ISO 11135 Second edition 2014 and ISO 10993-7:2008.
The shelf-life for three years had been validated in real-time aging test and the requirements on packaging for terminally sterilized medical device per ISO 11607-1:2006 are also met. The testing successfully demonstrated essential performance is achieved before and after the shelf life test.
The biocompatibility evaluations were conducted in accordance with the 2020 FDA Guidance document Use of International Standard ISO-10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The cytotoxicity, sensitization, intracutaneous irritation, system toxicity, In Vitro Hemolytic Properties Test, and pyrogen tests were performed to demonstrate the biocompatibility of the device.
Tests on Electromagnetic Compatibility and Electrical Safety were performed in accordance to requirements per AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-1-2 Edition 3: 2007-03.
9. Brief discussion of clinical tests
No clinical tests were performed.
10. Conclusions
The conclusion drawn from the nonclinical tests demonstrates that the subject device, the Matreneu® Percutaneous Balloon Compression Kit are as safe and effective as the legally marketed predicate device cleared under K940973.
§ 882.4535 Nonpowered neurosurgical instrument.
(a)
Identification. A nonpowered neurosurgical instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical procedures to cut, hold, or manipulate tissue. It includes specialized chisels, osteotomes, curettes, dissectors, elevators, forceps, gouges, hooks, surgical knives, rasps, scissors, separators, spatulas, spoons, blades, blade holders, blade breakers, probes, etc.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.