(24 days)
Not Found
No
The device description and intended use focus solely on the physical components and function of a PTA catheter, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is a medical catheter used for Percutaneous Transluminal Angioplasty (PTA) to open constricted arteries, which is a therapeutic procedure.
No
Explanation: The device, a Mini Ghost PTA Catheter, is used for Percutaneous Transluminal Angioplasty (PTA) to treat blockages in arteries. Its function is interventional (therapeutic) rather than diagnostic, as it is used to open vessels, not to identify or characterize a disease. While it uses fluoroscopy for placement, this is for guidance during the interventional procedure, not for diagnostic imaging itself.
No
The device description clearly describes a physical catheter with a balloon, shafts, guidewire lumen, and radiopaque markers, indicating it is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this is a catheter used for Percutaneous Transluminal Angioplasty (PTA) of arteries. This is a medical procedure performed within the body, not a test on a sample outside the body.
- Intended Use: The intended use is for a therapeutic procedure (PTA) to open narrowed arteries, not for diagnostic testing of a sample.
Therefore, the Mini Ghost PTA Catheter is a medical device used for a therapeutic intervention, not an in vitro diagnostic device.
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 coronary arteries. The catheter consists of a 3.5} polyamide outer shaft with a distally mounted balloon. The catheter terminates proximally in a bifurcated Y sleeve with separate extensions for the balloon and the guidewire. The inner tubing extends through the balloon and accommodates a 0.018" guidewire. The lumcn has radiopaque platinum marker bands under the balloon shoulders for placement using fluoroscopy. The catheter balloon diameter is stamoed 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
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 cleared Mini Ghost PTA Catheter (510(k) #K051343) and Z-MED Catheter (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. Copies are included as an attachment.
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 Mini Ghost 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
August 29, 2008
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 Mini Ghost 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 coronary arteries. The catheter consists of a 3.5} polyamide outer shaft with a distally mounted balloon. The catheter terminates proximally in a bifurcated Y sleeve with separate extensions for the balloon and the guidewire. The inner tubing extends through the balloon and accommodates a 0.018" guidewire. The lumcn has radiopaque platinum marker bands under the balloon shoulders for placement using fluoroscopy. The catheter balloon diameter is stamoed 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 cleared Mini Ghost PTA Catheter (510(k) #K051343) and Z-MED Catheter (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. Copies are included as an attachment.
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
| MODEL: | NUMED MINI GHOST PTA
CATHETER | NUMED MINI GHOST PTA
CATHETER - ADDT'L LENGTHS |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | 3.5F | 3.5F |
| Guidewire Size: | 0.018" | 0.018" |
| Usable Length: | 40cm - 150cm | 40cm - 150cm |
| Balloon Diameter: | 2mm - 6mm | 2mm - 6mm |
| Balloon Length: | 2cm - 10cm | 1cm - 10cm |
| Materials: | Shaft: Pebax
Balloon: PES2
Image Band: Platinum | Shaft: Pebax
Balloon: PES2
Image Band: Platinum |
| Construction: | Coaxial construction with
distally mounted non-compliant
balloon. | Coaxial construction with
distally mounted non-compliant
balloon. |
Comparison Information:
RISK ANALYSIS
Copies of The Risk Reports are attached.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 6 2008
NuMED, Inc. c/o Ms. Nichelle LaFlesh Regulatory Affairs Manager 2880 Main Street Hopkinton, NY 12965
Re: K082524
Trade/Device Name: Mini Ghost PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: DQY Dated: August 29, 2008 Received: September 2, 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, 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 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
3
Page 2 - Ms. Nichelle LaFlesh
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.
una R. buchner
A 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:
- 트 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.
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)
Dana R. bochner
(Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices
510(k) number K082524
Page 1 of 1