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.

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.

AI/ML Overview

The provided text describes a 510(k) summary for the NuMED Mini Ghost PTA Catheter. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically a study proving performance against specific acceptance criteria.

Therefore, the document does not contain the following information regarding acceptance criteria and a study proving a device meets them in the way usually associated with novel device performance evaluation:

A table of acceptance criteria and the reported device performance: No such table is presented. The comparison table focuses on device specifications (shaft size, guidewire size, materials, etc.) rather than performance metrics with acceptance limits.
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no clinical performance study described.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI-based diagnostic device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an AI-based diagnostic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

However, the document does describe the performance evaluation conducted for device clearance, which is primarily focused on bench testing and biocompatibility testing to establish substantial equivalence.

Here's a breakdown of the relevant information from the provided text regarding device performance evaluation:

Biocompatibility Testing:

Acceptance Criteria: Implicitly, the materials must demonstrate biocompatibility in compliance with the Tripartite Biocompatibility Guidance for Medical Devices.
Reported Device Performance: "Test results indicate that all materials demonstrate the biocompatibility of the NuMED catheter and are on file at NuMED, Inc."
Study Description: The materials used in the Mini Ghost PTA Catheter are the same as those used in the predicate device, NuMED Z-MED PTA Catheter (K931009), which were tested for biocompatibility.

Laboratory (Bench) Testing:

Acceptance Criteria: Implicitly, the device must meet design specifications and functional requirements typical for PTA catheters. No specific numerical acceptance criteria are listed in the summary.
Reported Device Performance: "All bench testing was performed in accordance with GMP's and the results are kept on file at NuMED, Inc."
Study Description: Bench testing was performed. No further details on specific tests or results are provided in the 510(k) summary (they are stated to be on file).

Substantial Equivalence Comparison (Functional and Material Performance):

While not a "study" in the traditional sense of a clinical trial, the 510(k) submission relies on a comparison table to the predicate device to demonstrate that the new device performs similarly or is safe and effective for its intended use.

Feature	NuMED Z-MED PTA Catheter (Predicate)	NuMED MINI GHOST PTA Catheter (New Device)	Comparison/Performance Implication
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.	Identical indications for use, suggesting similar functional expectations for PTA.
Materials	Shaft: PebaxBalloon: PES2Image Band: Platinum	Shaft: PebaxBalloon: PES2Image Band: Platinum	Identical materials, supporting the biocompatibility claim and suggesting similar material performance (e.g., strength, flexibility).
Construction	Coaxial construction with distally mounted non-compliant balloons.	Coaxial construction with distally mounted non-compliant balloon.	Identical construction principle, indicating similar mechanical behavior and delivery mechanism.
Shaft Size	5F - 9F	3.5F	Smaller shaft size, indicating suitability for smaller vessels, which is consistent with the "Mini Ghost" name and suggests an expansion of utility rather than a change in core function.
Guidewire Size	0.025" and 0.035"	0.018"	Smaller guidewire size, aligning with the smaller shaft size for use in smaller vessels.
Usable Length	75cm - 120cm	40cm - 120cm	Wider range, including shorter lengths, providing more options for different anatomical access points.
Balloon Diameter	2mm - 25mm	2mm - 6mm	Smaller range of balloon diameters, consistent with the device being for "small vessels" PTA.
Balloon Length	1cm - 15cm	2cm - 10cm	Smaller range of balloon lengths, also consistent with small vessel applications.

In summary, the provided text describes a 510(k) submission that demonstrates substantial equivalence primarily by:

Stating identical biocompatible materials to a previously cleared predicate device.
Confirming bench testing was performed according to GMPs, with results on file (but not detailed in the summary).
Providing a comparison table highlighting that the new device shares the same intended use, materials, and fundamental construction as the predicate, with modifications (smaller sizes) that are consistent with its "Mini Ghost" designation for small vessel PTA. The changes are presented as variations within the same device category, not as requiring new performance studies to prove efficacy or safety in a new domain.

Summary

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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.

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Comparison Information:
MODEL:	NUMED Z-MED PTACATHETER	NUMED MINI GHOST PTACATHETER
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: PebaxBalloon: PES2Image Band: Platinum	Shaft: PebaxBalloon: PES2Image Band: Platinum
Construction:	Coaxial construction withdistally mounted non-compliantballoons.	Coaxial construction withdistally mounted non-compliantballoon.

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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

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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

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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

Page 1 of 1

Regulation Number and Section

§ 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).