(161 days)
Not Found
No
The device description and performance studies focus on the physical, chemical, and biological properties of a mechanical balloon compression kit. There is no mention of AI, ML, image processing for analysis, or any data-driven algorithms.
Yes
The device is intended to treat trigeminal neuralgia by relieving compression of nerve fibers through balloon expansion, which constitutes therapeutic action.
No
The device description indicates it is used for a Percutaneous Balloon Compression (PBC) procedure to treat trigeminal neuralgia by relieving compression and causing injury through micro-balloon expansion. This describes a therapeutic intervention, not a diagnostic one.
No
The device description explicitly lists multiple physical components (balloon catheter, puncture needle, syringe, connector, and pressure gauge) and describes a physical procedure involving these components. There is no mention of software as a component or primary function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for a surgical procedure (Percutaneous Balloon Compression) to treat trigeminal neuralgia. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a kit containing instruments (balloon catheter, needle, syringe, etc.) used to perform this procedure. It is used to physically manipulate tissue and apply pressure.
- Lack of In Vitro Testing: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) outside of the body to diagnose a condition. IVDs are designed for laboratory or point-of-care testing of biological specimens.
The device is clearly intended for a therapeutic procedure performed in vivo (within the living body), which is the opposite of in vitro (in glass, or outside the living body).
N/A
Intended Use / Indications for Use
The Matreneu Percutaneous Balloon Compression Kit is intended to the Percutaneous Balloon Compression (PBC) procedure for primary trigeminal neuralgia.
Product codes (comma separated list FDA assigned to the subject device)
HAO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray fluoroscopy
Anatomical Site
meniscus of the trigeminal nerve in Meckel's cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The subject device expected to be used in a sterile operating room.
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)
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.
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
§ 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.
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)
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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 Times |
| Square, 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 MICROCOMPRESSION
SET |
|-------------------|-----------------------------------------|
| 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.
| Comparison
item | Subject Device: Matreneu®
Percutaneous Balloon
Compression Kit | Predicate Device: MULLAN
GANGLION
MICROCOMPRESSION
SET(K940973) | Comments |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product
Code | HAO | HAO | Same |
| Regulation
Number | 21 CFR § 882.4535 | 21 CFR § 882.4535 | Same |
| Classificatio
n | Class I | Class I | Same |
| Type of use | Prescription Use | Prescription Use | Same |
| Intended
use &
Indication
s for Use | The Matreneu
Percutaneous Balloon
Compression Kit is
intended to be used to the
Percutaneous Balloon
Compression (PBC)
procedure for primary
trigeminal neuralgia. | The Mullan Percutaneous
Trigeminal Ganglion
Microcompression Set is
intended for use in the
percutaneous treatment of
trigeminal neuralgia. This
set is supplied sterile in a
peel - open package and is
intended for one - time use. | Same |
| Applicable
user | The subject device is
indicated for patients with
trigeminal neuralgia treated
by compression | The subject device is
indicated for patients with
trigeminal neuralgia treated
by compression | Same |
| Comparison
item | Subject Device: Matreneu®
Percutaneous Balloon
Compression Kit | Predicate Device: MULLAN
GANGLION
MICROCOMPRESSION
SET(K940973) | Comments |
| neurosurgery. | neurosurgery. | | |
| Environment
of use | The subject device
expected to be used in a
sterile operating room. | The subject device
expected to be used in a
sterile 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 |
| Sterilization
method and
SAL | ETO sterile
SAL=10-6 | ETO sterile
SAL=10-6 | Same |
| Components | Balloon catheter
Puncture needle
Syringe
Connector
Pressure gauge | Microcompression Balloon
Catheter
Needle with stylet
Syringe
Scalpel
Needle
Angled needle gauge
Gauze pad
Adhesive bandage | Different
(Issue 1) |
| Working
principle | 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 slowly inject
the contrast agent to fill the
| 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 slowly 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,
so as to treat trigeminal
neuralgia. | 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.