(28 days)
No
The device description and summary of performance studies describe a mechanical balloon catheter and do not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is used for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions in peripheral vasculature and dialysis fistulae, which is a therapeutic intervention.
No
Explanation: The device is a balloon dilatation catheter used for therapeutic procedures (angioplasty and post-dilation of stents) to treat obstructive lesions. It does not gather information for diagnosis.
No
The device description clearly details a physical catheter with a balloon, guidewire lumen, and other hardware components. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for a medical procedure (Percutaneous Transluminal Angioplasty) performed within the patient's body to treat physical conditions (obstructive lesions).
- Device Description: The description details a physical catheter with a balloon designed for mechanical dilation of blood vessels. It does not mention any components or functions related to analyzing samples taken from the body (like blood, urine, or tissue).
- Lack of IVD Characteristics: There is no mention of reagents, assays, sample analysis, or any other typical characteristics of an in vitro diagnostic device.
IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device is a therapeutic device used to treat a condition directly within the body.
N/A
Intended Use / Indications for Use
The Jade PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, poplited, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilation of balloon expandable and self-expanding stents in the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
LIT
Device Description
The JADE PTA Balloon Dilatation Catheters is now also available as an over-the-wire balloon catheter for peripheral indications. The balloon diameters range from 1.5mm to 6.0mm and balloon lengths range from 20mm to 240mm, with 90cm, 150cm and 200cm catheter lengths. The balloon material is made of a minimally compliant material with a rated burst pressure of 18 atmospheres for 5.0-6.0mm and 20atm for 1.5-4.0mm. Hydrophilic lubricious coatings are applied to the distal section of the catheter. The shaft of the catheter is composed of a proximal shaft and a distal shaft. The distal shaft is composed of a distal outer tube and tri-extrusion inner tube with a balloon welded to both tubes at the distal tip to aid in tracking through vasculature. The proximal shaft is composed of a proximal outer tube and tri-extrusion inner tube that are bonded to a female luer connector, with the proximal outer tube allowing for proximal pushability with a smooth transition to the distal shaft. The inner lumen of the catheter accepts a maximum 0.014 inch (0.36mm) guidewire. The guidewire enters the catheter tip and advances coaxially out the hub guidewire lumen. Two radiopaque marker bands are positioned within the balloon shoulder, and for balloons of working length 180-240mm, two more marker bands (four marker bands in total) are positioned in the middle of the balloon. One marked section, for the 90cm catheter working length, or two marked sections, for the 150cm and 200cm catheter working lengths, are located on the proximal shaft to indicate catheter position relative to the tip of the guiding catheter or introducer sheath. The Y-type hub is bonded on the proximal end of the catheter at the entrance to the inflation lumen and the guidewire lumen. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature, including iliac, femoral, poplited, infra-popliteal, and renal arteries; native or synthetic arteriovenous dialysis fistulae
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)
Performance Testing:
- Visual Inspection
- Marker Band Radiopacity
- Dimensional Verification
- Coating Integrity
- Particulate Evaluation
- Balloon Preparation, Deployment, and Retraction
- Balloon Burst
- Balloon Burst (in-stent)
- Balloon Compliance
- Balloon Fatigue
- Balloon Fatigue (in-stent)
- Balloon Inflation and Deflation Time
- Flexibility and Kink
- Torque Strength
- Tip Pull Strength
- Catheter Bond Strength
Biocompatibility:
- Cytotoxicity
- ISO Intracutaneous Irritation
- Sensitization ISO Guinea Pig
- Acute Systemic Toxicity
- Material-mediated Pyrogenicity
- Hemocompatibility
- Hemolysis
- Complement Activation
- In vivo Thromboresistance
- Genotoxicity
- Bacterial Mutagenicity
- In Vitro Mouse Lymphoma Assay
Sterilization
Key results: The test results met all acceptance criteria, which are the same or similar to the predicate device, and ensure that the Jade PTA balloon dilation catheter design and construction are suitable for its intended use.
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.
OrbusNeich Jade (K173894)
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.
Bard Ultraverse (K192318), Boston Scientific Sterling (K141112), K132430
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
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 28, 2020
OrbusNeich Medical (Shenzhen) Co., Ltd. Mr. Daniel Zhang Regulatory Director No.1st Jinkui Road Futian Free Trade Zone Shenzhen, Guangdong 518038 China
Re: K201794
Trade/Device Name: Jade PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: June 23, 2020 Received: June 30, 2020
Dear Mr. Zhang:
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 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
1
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,
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
Jade PTA Balloon Dilatation Catheter
Indications for Use (Describe)
The Jade PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, poplited, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilation of balloon expandable and self-expanding stents in the peripheral vasculature.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (7/17)
3
510(k) Summary
This 510(k) Summary is submitted in accordance with 21 CFR 807.92(c).
| Submitter: | OrbusNeich Medical (Shenzhen) Co., Ltd.
1 Jinkui Road, Futian Free Trade Zone
Shenzhen, 518038, China |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Daniel Zhang |
| Date Prepared: | June 19, 2020 |
| Trade Name: | Jade PTA Balloon Dilatation Catheter |
| Common Name: | Percutaneous Transluminal Angioplasty (PTA) Catheter |
| Classification Name: | Catheter, Angioplasty, Peripheral, Transluminal (21 CFR 870.1250) |
| Product Code: | LIT |
| Predicate Device: | OrbusNeich Jade (K173894; cleared February 9, 2018) |
| Reference Device: | Bard Ultraverse (K192318; cleared October 3, 2019)
Boston Scientific Sterling (K141112; cleared July 16, 2014 & K132430;
cleared October 17, 2013) |
| Device Description: | The JADE PTA Balloon Dilatation Catheters is now also available as an over-the-
wire balloon catheter for peripheral indications. The balloon diameters range from
1.5mm to 6.0mm and balloon lengths range from 20mm to 240mm, with 90cm,
150cm and 200cm catheter lengths. The balloon material is made of a minimally
compliant material with a rated burst pressure of 18 atmospheres for 5.0-6.0mm and
20atm for 1.5-4.0mm. Hydrophilic lubricious coatings are applied to the distal
section of the catheter.
The shaft of the catheter is composed of a proximal shaft and a distal shaft. The
distal shaft is composed of a distal outer tube and tri-extrusion inner tube with a
balloon welded to both tubes at the distal tip to aid in tracking through vasculature.
The proximal shaft is composed of a proximal outer tube and tri-extrusion inner tube
that are bonded to a female luer connector, with the proximal outer tube allowing
for proximal pushability with a smooth transition to the distal shaft. The inner lumen
of the catheter accepts a maximum 0.014 inch (0.36mm) guidewire. The guidewire
enters the catheter tip and advances coaxially out the hub guidewire lumen. Two
radiopaque marker bands are positioned within the balloon shoulder, and for
balloons of working length 180-240mm, two more marker bands (four marker bands
in total) are positioned in the middle of the balloon. One marked section, for the
90cm catheter working length, or two marked sections, for the 150cm and 200cm
catheter working lengths, are located on the proximal shaft to indicate catheter
position relative to the tip of the guiding catheter or introducer sheath. The Y-type
hub is bonded on the proximal end of the catheter at the entrance to the inflation
lumen and the guidewire lumen. The design of this dilatation catheter does not
incorporate a lumen for distal dye injections or distal pressure measurements. |
| Intended Use: | The JADE PTA Balloon Dilatation Catheter is indicated for Percutaneous
Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral,
ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of
obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device
is also indicated for post-dilation of balloon expandable and self-expanding stents
in the peripheral vasculature. |
| Technological Characteristics: | The subject and predicate devices are the same based on the following
technological elements:
■ the same indications for use
■ minimally-compliant balloon |
4
- nominal pressure of 12 atm
- rated burst pressure of 18/20 atm
- distal shaft
- hydrophilic coating on the distal section of the catheter
- silicone coating in the inner lumen
- . 0.014" guidewire compatibility
- . EO sterilization
The technological differences of the subject comparing with the predicate device are as follows:
- over-the-wire catheter shaft design (for catheter working lengths of 90, 150 and 200cm)
- . additional balloon lengths of 150, 180, and 240mm
- over-the-wire hub design
- specific materials selected for proximal shaft
- dimensions of proximal shaft components and catheter
5
Performance Data:
The following testing was performed to support the over-the-wire shaft design of the Jade PTA balloon dilatation catheter:
- . Performance Testing
- Visual Inspection ●
- Marker Band Radiopacity .
- Dimensional Verification .
- . Coating Integrity
- Particulate Evaluation ●
- . Balloon Preparation, Deployment, and Retraction
- . Balloon Burst.
- . Balloon Burst (in-stent)
- . Balloon Compliance
- Balloon Fatigue
- . Balloon Fatigue (in-stent)
- . Balloon Inflation and Deflation Time
- Flexibility and Kink .
- Torque Strength ●
- . Tip Pull Strength
- Catheter Bond Strength
- Biocompatibility ■
- Cytotoxicity ●
- ISO Intracutaneous Irritation .
- Sensitization ISO Guinea Pig .
- Acute Systemic Toxicity
- Material-mediated Pyrogenicity ●
- Hemocompatibility ●
- Hemolysis
- . Complement Activation
- . In vivo Thromboresistance
- Hemolysis
- . Genotoxicity
- Bacterial Mutagenicity ●
- In Vitro Mouse Lymphoma Assay .
- Sterilization
The test results met all acceptance criteria, which are the same or similar to the predicate device, and ensure that the Jade PTA balloon dilation catheter design and construction are suitable for its intended use.
Conclusion:
This information supports a determination of substantial equivalence between the Jade PTA balloon dilatation catheter and the predicate device described above.