(50 days)
No
The device description and performance studies focus solely on the physical characteristics and mechanical performance of a balloon catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions in peripheral vasculature and post-dilation of stents, which are medical treatments for diseases.
No
Explanation: The device is a balloon dilatation catheter used for therapeutic purposes (angioplasty and post-dilation of stents) to treat obstructive lesions. It does not perform diagnostic functions such as imaging, measuring, or analyzing to identify a disease or condition. The description explicitly states it "does not incorporate a lumen for distal dye injections or distal pressure measurements," which would be diagnostic features.
No
The device description clearly details a physical medical device (catheter with balloon) and its material components, not a software-only product.
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 on a patient's body to treat conditions within their peripheral vasculature. This is an in vivo procedure.
- Device Description: The description details a physical catheter with a balloon designed to be inserted into blood vessels. This is a medical device used for intervention within the body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, disease, or congenital abnormality. This device does not perform such analysis on specimens.
The device is a therapeutic medical device used for a surgical/interventional procedure, not a diagnostic test performed on samples outside 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
LIT
Device Description
The JADE Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter is a rapid exchange balloon catheter for peripheral indications with a working length of 150cm. The minimally compliant balloons, available in diameters from 1.5-6.0mm and lengths from 15- 120mm, can be inflated by injecting dilute contrast media solution through the trailing hub of the catheter. The balloon material is made of a minimally compliant material with a rated burst pressure of 20 atm (Ø1.5-4.0mm) or 18atm (Ø4.5-6.0mm). Hydrophilic lubricious coatings are applied to the distal section of the catheter. The proximal shaft of the catheter is composed of a female luer connector bonded to a nylon tube which is internally supported by a stainless steel hypotube. Two radiopaque platinum/iridium marker bands are located within the balloon shoulders. The internal lumen of the catheter accepts a maximum 0.014 inch (0.36mm) guidewire. The guidewire enters the catheter tip and advances coaxially out the RX port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guidewire. Two marked sections, 3mm in length located on the proximal shaft specifically designed to be highly visible, indicate catheter position relative to the guiding catheter or guiding sheath. 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
iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and 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)
Both in vitro performance tests, such as dimensional verification, balloon preparation, deployment, and retraction, balloon rated burst pressure, balloon fatigue, balloon compliance, balloon inflation and deflation time, catheter bond strength, tip pull strength, flexibility and kinking, torque strength, radiopacity, coating integrity, particulate evaluation, within stent balloon burst strength, and within stent balloon fatigue and also biocompatibility tests, such as cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility (hemolysis, partial thromboplastin time, platelet and leukocyte counts, complement activation, and in vivo thromboresistance). pyrogenicity. and genotoxicity (bacterial mutagenicity and in vitro mouse lymphoma) were conducted on the Jade PTA balloon dilatation catheter. The test results met all acceptance criteria, were similar to predicate devices, and ensure that the Jade PTA balloon dilatation 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.
Sterling (K141150)
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.
Sapphire NC Plus (K162209), NanoCross Elite (K141118)
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
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February 9, 2018
OrbusNeich Medical Trading, Inc. Mr. John D. Pazienza Senior Director, Engineering 5363 NW 35th Avenue Fort Lauderdale, FL 33309
Re: K173894
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: December 20, 2017 Received: December 21, 2017
Dear Mr. Pazienza:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Kenneth J. Cavanaugh -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173894
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, 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.
| 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) |
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510(k) Summary
This 510(k) Summary is submitted in accordance with 21 CFR 807.92(c).
| Submitter: | OrbusNeich Medical Trading, Inc.
5363 NW 35th Avenue
Fort Lauderdale, FL 33309
Phone: 954.730.0711
Fax: 954.730.7601 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John D. Pazienza |
| Date Prepared: | February 8, 2018 |
| 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: | Sterling (K141150; cleared September 25, 2014) |
| Reference Devices: | Sapphire NC Plus (K162209; cleared October 6, 2016)
NanoCross Elite (K141118; cleared July 18, 2014) |
| Device Description: | The JADE Percutaneous Transluminal Angioplasty (PTA) Balloon
Dilatation Catheter is a rapid exchange balloon catheter for peripheral
indications with a working length of 150cm. The minimally compliant
balloons, available in diameters from 1.5-6.0mm and lengths from 15-
120mm, can be inflated by injecting dilute contrast media solution
through the trailing hub of the catheter. The balloon material is made
of a minimally compliant material with a rated burst pressure of 20 atm
( $Ø1.5-4.0mm$ ) or 18atm ( $Ø4.5-6.0mm$ ). Hydrophilic lubricious
coatings are applied to the distal section of the catheter. The proximal
shaft of the catheter is composed of a female luer connector bonded to
a nylon tube which is internally supported by a stainless steel
hypotube. Two radiopaque platinum/iridium marker bands are located
within the balloon shoulders. The internal lumen of the catheter
accepts a maximum 0.014 inch (0.36mm) guidewire. The guidewire
enters the catheter tip and advances coaxially out the RX port, thereby
allowing both coaxial guidance and rapid exchange of catheter with a
single standard length guidewire. Two marked sections, 3mm in
length located on the proximal shaft specifically designed to be highly
visible, indicate catheter position relative to the guiding catheter or
guiding sheath. The design of this dilatation catheter does not
incorporate a lumen for distal dye injections or distal pressure
measurements. |
4
- 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: Comparisons of the new and predicate devices show that the technological characteristics such as product performance, design, and intended use are substantially equivalent to the currently marketed predicate devices.
- Performance Data: Both in vitro performance tests, such as dimensional verification, balloon preparation, deployment, and retraction, balloon rated burst pressure, balloon fatigue, balloon compliance, balloon inflation and deflation time, catheter bond strength, tip pull strength, flexibility and kinking, torque strength, radiopacity, coating integrity, particulate evaluation, within stent balloon burst strength, and within stent balloon fatigue and also biocompatibility tests, such as cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility (hemolysis, partial thromboplastin time, platelet and leukocyte counts, complement activation, and in vivo thromboresistance). pyrogenicity. and genotoxicity (bacterial mutagenicity and in vitro mouse lymphoma) were conducted on the Jade PTA balloon dilatation catheter. The test results met all acceptance criteria, were similar to predicate devices, and ensure that the Jade PTA balloon dilatation catheter design and construction are suitable for its intended use.
- This information supports a determination of substantial equivalence Conclusion: between the Jade PTA balloon dilatation catheter and the predicate device described above.