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 coronary 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 separate extensions 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

This document is a 510(k) summary for a medical device called the NuMED Mini Ghost PTA Catheter. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted from this document.

Here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

The document does not state explicit numerical acceptance criteria for device performance in the way one might see for a diagnostic AI device (e.g., sensitivity > X%, specificity > Y%). Instead, the acceptance criteria are largely implied by establishing "substantial equivalence" to a predicate device, meaning the new device should perform similarly and be as safe and effective.

The reported device performance is conveyed through a comparison with the predicate device, focusing on shared characteristics and intended use.

Acceptance Criterion (Implied)	Reported Device Performance
Biocompatibility: Materials are biocompatible.	Materials are the same as those used in already cleared predicate devices (Mini Ghost PTA Catheter K051343 and Z-MED Catheter K931009) which were tested for biocompatibility in compliance with the Tripartite Biocompatibility Guidance for Medical Devices. Test results indicate biocompatibility and are on file.
Functional Performance (Bench Testing): Device meets functional specifications.	"All bench testing was performed in accordance with GMP's and the results are kept on file at NuMED. Inc." (Specific performance metrics are not detailed in this summary but are referenced as being on file and meeting GMPs). This implies physical characteristics like balloon inflation/deflation, guidewire compatibility, shaft flexibility, etc., would have been tested to ensure the device performs as intended and is comparable to the predicate.
Intended Use: Similar indications for use as predicate.	NuMED Mini Ghost PTA Catheter: "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 is identical to the indications for the predicate devices mentioned.
Technical Specifications: (Shaft Size, Guidewire Size, Usable Length, Balloon Diameter, Balloon Length, Materials, Construction) are equivalent or within acceptable range of predicate.	All listed technical specifications (Shaft Size: 3.5F, Guidewire Size: 0.018", Usable Length: 40cm-150cm, Balloon Diameter: 2mm-6mm, Balloon Length: 1cm-10cm, Materials: Shaft: Pebax, Balloon: PES2, Image Band: Platinum, Construction: Coaxial with distally mounted non-compliant balloon) are either identical to the predicate device, or in the case of "Balloon Length", the additional lengths are within the established safe and effective parameters, demonstrating equivalence to the predicate. The document presents two columns for "NuMED Mini Ghost PTA Catheter" and "NuMED Mini Ghost PTA Catheter - Addt'l Lengths" which are almost identical, indicating the "addt'l lengths" are simply extensions of the existing product line.
Safety: Device is as safe as legally marketed predicate devices.	Biocompatibility and the use of the same materials as previously cleared devices, along with bench testing performed under GMPs, are presented as evidence of safety. A "Risk Analysis" is mentioned as attached, implying identified risks are managed.

Regarding the "study that proves the device meets the acceptance criteria":

Based on the provided text, no clinical study proving the device meets numerical performance acceptance criteria was conducted for this 510(k) submission. Instead, the submission relies on:

Bench Testing: Laboratory (Bench) Testing was performed according to GMPs, and results are on file. This testing would verify the physical and mechanical properties of the device against design specifications.
Biocompatibility Testing: The materials used are identical to previously cleared devices which underwent biocompatibility testing in compliance with established guidance.
Comparison to Predicate: The primary "proof" for 510(k) clearance is demonstrating substantial equivalence to an already legally marketed device (the predicate). This means showing the new device has the same intended use, similar technological characteristics, and is as safe and effective as the predicate.

Given this context, the following information cannot be extracted or is not applicable:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable; no clinical test set described. Bench testing sample sizes would be internal to NuMED.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable; no clinical test set or ground truth described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable; no clinical test set described.

5. 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; this is a medical device (catheter) 510(k), not an AI diagnostic algorithm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable; this is a medical device (catheter) 510(k), not an AI diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For biocompatibility, the ground truth was the established standards and testing methods.
For bench testing, the ground truth was the engineering specifications and performance expectations for the device.
No clinical ground truth as no clinical study was conducted for this 510(k).

8. The sample size for the training set

Not applicable; this is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established

Not applicable; this is not an AI/ML device.

Summary

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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.

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MODEL:	NUMED MINI GHOST PTACATHETER	NUMED MINI GHOST PTACATHETER - ADDT'L LENGTHS
Indications:	• This catheter isrecommended forPercutaneousTransluminalAngioplasty (PTA) of thefemoral, iliac, and renalarteries. Thesecatheters are notdesigned to be used inthe coronary arteries.	• This catheter isrecommended forPercutaneousTransluminalAngioplasty (PTA) ofthe femoral, iliac, andrenal arteries. Thesecatheters are notdesigned to be used inthe 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: PebaxBalloon: PES2Image Band: Platinum	Shaft: PebaxBalloon: PES2Image Band: Platinum
Construction:	Coaxial construction withdistally mounted non-compliantballoon.	Coaxial construction withdistally mounted non-compliantballoon.

Comparison Information:

RISK ANALYSIS

Copies of The Risk Reports are attached.

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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

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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

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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

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).