(23 days)
Not Found
Not Found
No
The device description focuses on the mechanical components and materials of a balloon catheter for valvuloplasty, with no mention of software, algorithms, or data processing that would indicate AI/ML. The input imaging modality is fluoroscopy, which is a standard imaging technique, and there is no description of how this imaging data is processed by the device itself using AI/ML.
Yes
The device is a catheter designed for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve, which is a medical procedure used to treat pulmonary stenosis. This directly involves treating a medical condition and restoring normal function, thus making it a therapeutic device.
No
The device, NuCLEUS-X catheter, is intended for Percutaneous Transluminal Valvuloplasty (PTV), which is a therapeutic procedure to dilate a stenosed pulmonary valve, not to diagnose a condition.
No
The device description clearly details a physical catheter with various material components (polymeric tubing, polyamide, stainless steel, platinum marker bands) and a balloon for dilation, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve. This is a therapeutic procedure performed directly on the patient's body to treat a medical condition (pulmonary stenosis).
- Device Description: The device is a catheter with a balloon designed to physically dilate a valve within the body.
- Function: The device's function is to mechanically open a narrowed valve.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information for diagnosis.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) for a therapeutic intervention.
N/A
Intended Use / Indications for Use
This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.
- A patient with isolated pulmonary stenosis
- A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The NuCLEUS-X catheter is a coaxial catheter for use in for Percutaneous Transluminal Valvuloplasty (PTV) for mitral and aortic position and centered angioplasty applications. The outer body is made of polymeric tubing, and the inner tubing is comprised of a multi layer extrusion of polyamide (Vestamid PA12) that surrounds a braid of 304 LV Stainless Steel. The catheter features a molded proximal end bifurcate with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon made of polyamide. The balloon is designed with a waist formed into the middle of the balloon to allow accurate balloon placement. Upon reaching a specified pressure, the waist will expand to the rated balloon diameter and dilate the valve to the rated diameter. The distal lumen terminates at the tip of the catheter and will accept the 0.035" guidewire. This lumen has 3 radiopaque platinum marker bands. One under each of the balloon shoulders and one located at the "waist" or center of the balloon for placement using fluoroscopy. The catheter is white in color and the balloon material is clear. The catheter is packaged in a polyethylene sheath and is double packed in two heat sealed Tyvek pouches.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
pulmonary valve, mitral and aortic position
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)
Biocompatibility Testing: The materials used in the NuMED NuCLEUS-X PTV Catheter are the same as those used in the already approved Z-MED-X PTV Catheter (510(k) #K02722) which were tested for biocompatibility in compliance with the Tripartite Biocompatibility Guidance for Medical Devices. Test results indicate that all materials demonstrate the biocompatibility of the NuMED catheter and are on file at NuMED, Inc.
Laboratory (Bench) Testing: All bench testing was performed in accordance with GMP's and the results are kept on file at NuMED, Inc. Copies are included as an attachment.
RISK ANALYSIS: Attached is a copy of our FMECA showing our risk analysis of this product.
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.
NuMED Z-MED-X PTV Catheter
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
§ 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
KOS1680 p. & of 2
510(K) SUMMARY
June 13, 2008
JUL 1 0 2008
Submitted By: NuMED, Inc. , 2880 Main St., Hopkinton, NY 12965 (Ph) 315-328-4491
Contact Person: Nichelle LaFlesh
NuMED NuCLEUS-X PTV Catheter; 21 CFR 870.1250 - Percutaneous Device Name: Catheter
Predicate Devices: NuMED Z-MED-X PTV Catheter
Device Description: The NuCLEUS-X catheter is a coaxial catheter for use in for Percutaneous Transluminal Valvuloplasty (PTV) for mitral and aortic position and centered angioplasty applications. The outer body is made of polymeric tubing, and the inner tubing is comprised of a multi layer extrusion of polyamide (Vestamid PA12) that surrounds a braid of 304 LV Stainless Steel. The catheter features a molded proximal end bifurcate with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon made of polyamide. The balloon is designed with a waist formed into the middle of the balloon to allow accurate balloon placement. Upon reaching a specified pressure, the waist will expand to the rated balloon diameter and dilate the valve to the rated diameter. The distal lumen terminates at the tip of the catheter and will accept the 0.035" guidewire. This lumen has 3 radiopaque platinum marker bands. One under each of the balloon shoulders and one located at the "waist" or center of the balloon for placement using fluoroscopy. The catheter is white in color and the balloon material is clear. The catheter is packaged in a polyethylene sheath and is double packed in two heat sealed Tyvek pouches.
The materials used in the NuMED NuCLEUS-X PTV Catheter are Biocompatibility Testing: the same as those used in the already approved Z-MED-X PTV Catheter (510(k) #K02722) which were tested for biocompatibility in compliance with the Tripartite Biocompatibility Guidance for Medical Devices.
Test results indicate that all materials demonstrate the biocompatibility of the NuMED catheter and are on file at NuMED, Inc.
Laboratory (Bench) Testing: All bench testing was performed in accordance with GMP's and the results are kept on file at NuMED, Inc. Copies are included as an attachment.
Intended Use: This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.
- 비 A patient with isolated pulmonary stenosis.
- 프 A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.
1
| MODEL: | NUMED Z-MED-X PTV
CATHETER | NUMED NUCLEUS-X PTV
CATHETER |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications: | This catheter is recommended for
Percutaneous Transluminal
Valvuloplasty (PTV) of the
pulmonary valve.
-
A patient with isolated
pulmonary stenosis. -
A patient with valvular
pulmonary stenosis with
other minor congenital
heart disease that does not
require surgical
intervention. | This catheter is recommended for
Percutaneous Transluminal
Valvuloplasty (PTV) of the
pulmonary valve. -
A patient with isolated
pulmonary stenosis. -
A patient with valvular
pulmonary stenosis with
other minor congenital
heart disease that does not
require surgical
intervention. |
| Shaft Size: | 6-9Fr | 9Fr |
| Guidewire Size: | 0.035" | 0.035" |
| Balloon Diameter: | 8-10mm, 12mm, 14-16mm,
18mm, 20mm, 22mm, 25mm,
28mm, and 30mm | 18mm, 20mm, 22mm, 25mm,
28mm, and 30mm. |
| Balloon Length: | 2-6cm | 4-6cm |
| Materials: | Shaft: Pebax
Balloon: PES2
Image Band: Platinum | Shaft: Pebax
Balloon: PES2
Image Band: Platinum |
Comparison Information:
RISK ANALYSIS
Attached is a copy of our FMECA showing our risk analysis of this product.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 10 2008
NuMED, Inc. c/o Ms. Nichelle LaFlesh Regulatory Affairs Manager 2880 Main Street Hopkinton, NY 12965
Re: K081680
Trade/Device Name: NuCLEUS-X Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: DQY Dated: June 16, 2008 Received: June 17, 2008
Dear Ms. LaFlesh:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
3
Page 2 -- Ms. Nichelle LaFlesh
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
1081680 510(k) Number (if known):
Device Name: NuCLEUS-X PTV Catheter
Indications For Use:
This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.
- A patient with isolated pulmonary stenosis 트
- A patient with valvular pulmonary stenosis with other minor congenital 트 heart disease that does not requrie surgical intervention.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K0 81 680
6/16/2008