(66 days)
No
The description focuses on the physical components and intended use of a balloon catheter for angioplasty, with no mention of AI or ML capabilities.
Yes
The device, a PTA catheter, is used for Percutaneous Transluminal Angioplasty, which is a medical procedure aimed at widening narrowed or obstructed blood vessels to improve blood flow, thereby treating a physiological condition.
No
This device is a therapeutic angioplasty catheter used to treat vessels, not diagnose conditions.
No
The device description clearly details a physical catheter with a balloon, shafts, lumens, and marker bands, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body (in vitro means "in glass" or "in the lab").
- This device is a catheter used for Percutaneous Transluminal Angioplasty (PTA). This is a medical procedure performed inside the body to widen narrowed arteries.
The description clearly indicates a device used for a therapeutic procedure within the patient's body, not for testing samples in a laboratory setting.
N/A
Intended Use / Indications for Use
This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Mini Ghost PTA Catheter is a coaxial catheter indicated for PTA of small vessels outside of the heart. This catheter is not intended for use in the corronary arteries. The catheter consists of a 3.5F polyamide outer shaft with a distally mounted balloon. The catheter terminates proximally in a bifurcated Y sleeve with mounted bandem. For the balloon and the guidewire. The inner tubing extends through the balloon and accommodates a 0.018" guidewire. The lumen has radiopaque platinum marker bands under the balloon shoulders for placement using fluoroscopy. The catheter balloon diameter is stamped onto the Y sleeve and the balloon extension is labeled with balloon diameter x balloon length x introducer size x shaft size x usable length x guidewire size and the catheter lot number. 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
femoral, iliac, and renal arteries (not for coronary arteries)
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 Mini Ghost PTA Catheter are the same as those used in the already approved Z-MED PTA Catheter (510(k) #K931009) 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.
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 PTA 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.
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
510(K) SUMMARY
June 27, 2005
Submitted By: NuMED, Inc. , 2880 Main St., Hopkinton, NY 12965 (Ph) 315-328-4491
Contact Person: Nichelle LaFlesh
Device Name: NuMED Mini Ghost PTA Catheter; 21 CFR 870.1250 - Percutaneous Catheter
Predicate Devices: NuMED Z-MED PTA Catheter
Device Description: The Mini Ghost PTA Catheter is a coaxial catheter indicated for PTA of small vessels outside of the heart. This catheter is not intended for use in the corronary arteries. The catheter consists of a 3.5F polyamide outer shaft with a distally mounted balloon. The catheter terminates proximally in a bifurcated Y sleeve with mounted bandem. For the balloon and the guidewire. The inner tubing extends through the balloon and accommodates a 0.018" guidewire. The lumen has radiopaque platinum marker bands under the balloon shoulders for placement using fluoroscopy. The catheter balloon diameter is stamped onto the Y sleeve and the balloon extension is labeled with balloon diameter x balloon length x introducer size x shaft size x usable length x guidewire size and the catheter lot number. The catheter is packaged in a polyethylene sheath and is double packed in two heat sealed Tyvek pouches.
Biocompatibility Testing:
The materials used in the NuMED Mini Ghost PTA Catheter are the same as those used in the already approved Z-MED PTA Catheter (510(k) #K931009) 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.
Intended Use:
This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.
1
| Comparison Information: | ||
|---|---|---|
| MODEL: | NUMED Z-MED PTA | |
| CATHETER | NUMED MINI GHOST PTA | |
| CATHETER | ||
| Indications: | This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries. | This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries. |
| Shaft Size: | 5F - 9F | 3.5F |
| Guidewire Size: | 0.025" and 0.035" | 0.018" |
| Usable Length: | 75cm - 120cm | 40cm - 120cm |
| Balloon Diameter: | 2mm - 25mm | 2mm - 6mm |
| Balloon Length: | 1cm - 15cm | 2cm - 10cm |
| Materials: | Shaft: Pebax | |
| Balloon: PES2 | ||
| Image Band: Platinum | Shaft: Pebax | |
| Balloon: PES2 | ||
| Image Band: Platinum | ||
| Construction: | Coaxial construction with | |
| distally mounted non-compliant | ||
| balloons. | Coaxial construction with | |
| distally mounted non-compliant | ||
| balloon. |
.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized, curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 8 8 2005
NuMED, Inc. c/o Ms. Nichelle R. LaFlesh Regulatory Affairs Manager 2880 Main St Hopkinton, NY 12965
Re: K051343
Mini Ghost PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: June 27, 2005 Received: June 28, 2005
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 for assessment 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.
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 or any Federal statutes and regulations administered by other Federal agencies. You must
3
Page 2 - Ms. Nichelle R. LaFlesh
comply with all the Act's requirements, including, but not limited to: registration and listing (21 comply will an the Act 3 requirements, nieraally, and manufacturing practice requirements as set as a CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product lauation control promotio (Seting your device as described in your Section 510(k) This letter will anow you to oegin management of your device of your device to a legally premarket notification: "The PDF intember of 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 If you desire specific advice 101 your at (240) 276-0120. Also, please note the regulation entitled, Comaci the Office of Complaners and station" (21CFR Part 807.97). You may obtain Misolaliuning by reference to premation on your responsibilities under the Act from the Division of Small biller general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
R. Vachner
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
510(k) Number (if known):
Device Name: Mini Ghost PTA Catheter
Indications For Use:
- This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the l femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.
,,
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)
Durra P. V. Ames
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K 05
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