The NuMED Z-MED™ catheter is a coaxial catheter recommended for Balloon Aortic Valvuloplasty. The catheter's inner and outer shafts are constructed of polyamide tubing. 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. This balloon is of the non-compliant variety. Both the shaft size and the guidewire size vary according to balloon diameter. The distal lumen terminates at the tip of the catheter and will accept the passage of the appropriate guidewire. The lumen has radiopaque platinum marker band(s), centered or under the balloon shoulders, for placement using fluoroscopy. The catheter is white in color and the balloon material is clear. The catheter balloon diameter and name is stamped onto the Y sleeve and the balloon extension is labeled with the catheter specifications and lot number. The catheter is packaged in a polyethylene sheath and is double packed in two heat sealed Tyvek pouches. The NuMED Z-MED II™ catheter is a coaxial catheter recommended for Balloon Aortic Valvuloplasty. The catheter's inner and outer shafts are constructed of polyamide tubing. 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. This balloon is of the non-compliant variety. Both the shaft size and the guidewire size vary according to balloon diameter. The distal lumen terminates at the tip of the catheter and will accept the passage of the appropriate guidewire. The lumen has radiopaque platinum marker band(s), centered or under the balloon shoulders, for placement using fluoroscopy. The catheter is white in color and the balloon material is clear. The catheter balloon diameter and name is stamped onto the Y sleeve and the balloon extension is labeled with the catheter specifications and lot number. The catheter is packaged in a polyethylene sheath and is double packed in two heat sealed Tyvek pouches.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance Study

The K122012 submission for the Z-MED and Z-MED II Catheters primarily relies on in-vitro (bench) testing and a review of existing clinical data for safety and effectiveness. No specific algorithms or human-in-the-loop performance studies are described as this is a medical device (catheter), not an AI/software device.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text details in-vitro test results for the Z-MED and Z-MED II catheters, as well as two predicate devices (NuCLEUS-X and NuCLEUS). The table below focuses on the Z-MED and Z-MED II results as the subject devices.

Test Performed	Acceptance Criteria	Z-MED Results	Z-MED II Results
Visual Inspection	The catheters shall be free from contamination, discoloration, and any form of damage that could impact the proper functioning of the device.	All catheters were visually inspected without any anomalies.	All catheters were visually inspected without any anomalies.
Balloon Preparation Test	Each catheter shall be prepped per the procedure without functional difficulties or anomalies.	All catheters tested were without functional difficulties or anomalies.	All catheters tested were without functional difficulties or anomalies.
Diameter and Profile Test	The balloon diameter at rated burst pressure shall be within +/- 10% of the labeled balloon diameter and the samples should fit through the selected introducer with no problems.	All catheters met the acceptance criteria.	All catheters met the acceptance criteria.
Balloon Distensibility	The results must demonstrate that the balloon diameter is within +/- 10% of the labeled diameter at the RBP and will not be significantly increased at increasingly higher pressures.	All data obtained demonstrates that the balloon diameter is within +/- 10% of the labeled diameter at the RBP. All data obtained demonstrates that the diameter of the balloons will not be significantly increased at increasingly higher pressures.	All data obtained demonstrates that the balloon diameter is within +/- 10% of the labeled diameter at the RBP. All data obtained demonstrates that the diameter of the balloons will not be significantly increased at increasingly higher pressures.
Balloon Minimum Burst Strength	The results must show statistically that with at least 95% confidence, 99.9% of the balloons will not burst at or below the maximum recommended rated burst pressure.	(Specific pressures listed for various balloon sizes, all indicating performance at or above the acceptance criteria)	(Specific pressures listed for various balloon sizes, all indicating performance at or above the acceptance criteria)
Repeated Balloon Inflation (Balloon Fatigue) Test	No breaks allowed.	No Breaks.	No Breaks.
Balloon Inflation/Deflation Test	Inflation achieved in less than 12 seconds and deflation achieved in less than 20 seconds.	All catheters met the established acceptance criteria.	All catheters met the established acceptance criteria.
Balloon Deflatability Test	There should be no interference with balloon deflation.	All catheters met the established acceptance criteria.	All catheters met the established acceptance criteria.
Tip Pull and Torque Test	Must withstand at least 10 turns without breaking.	No breaks.	No breaks.
Bond Strength Test	All bonds must withstand at least 3 lbs. of pull strength.	All bonds met the established acceptance criteria.	All bonds met the established acceptance criteria.
Catheter Body Maximum Pressure Test	All samples must withstand 30 ATM (400psi).	>30 ATM	>30 ATM

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for In-Vitro Testing: The document does not explicitly state the numerical sample size for each in-vitro test (e.g., how many catheters were visually inspected or burst tested). It refers to "All catheters" or "All samples" meeting criteria, indicating that a sufficient number were tested.
Data Provenance (Clinical):
- Country of Origin: The clinical evaluation report was prepared to meet the requirements of the Medical Device Directive MOD 93/42/EEC (European Union standard). The clinical use of the Z-MED and Z-MED II catheters for BAV and BMV is mentioned in "those countries where they are used," and for BPV in "the United States."
- Retrospective/Prospective: The clinical information gathered appears to be a retrospective review of existing clinical literature, device history, previous sales, and reported complaints. It references "Numerous clinical studies reported in literature" and "200 patients" without incidents from BAV prior to TAVI.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable and not provided in the context of this submission. The tests described are in-vitro bench tests for a physical medical device (catheter), which do not typically involve experts establishing ground truth in the way it's done for diagnostic AI/software. The ground truth for in-vitro tests is based on objective physical measurements and engineering specifications.

For the clinical context, the "ground truth" refers to observations from actual patient use, as reported in clinical literature and through device monitoring. No specific number or qualification of experts reviewing patient outcomes is provided beyond the implicit understanding that medical professionals conducted the procedures and reported outcomes.

4. Adjudication Method for the Test Set

This is not applicable for the in-vitro bench testing described. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or for establishing ground truth in cases where there's variability in interpretation (e.g., image analysis by multiple radiologists). The in-vitro tests are objective physical measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study is not applicable and not mentioned. This type of study is relevant for diagnostic devices, especially those involving human interpretation of data, often comparing human performance with and without AI assistance. The Z-MED and Z-MED II are interventional catheters, not diagnostic devices or AI software. There's no AI component mentioned to compare human readers with or without.

6. Standalone (Algorithm Only) Performance Study

This is not applicable and not mentioned. The devices are physical catheters, not algorithms or software. Therefore, there is no standalone (algorithm only) performance to evaluate.

7. Type of Ground Truth Used

In-Vitro Testing: The ground truth for the in-vitro tests is established by the predefined engineering specifications and acceptance criteria outlined in the table (e.g., balloon diameter within +/- 10% of labeled, no breaks, inflation/deflation times). These are objective, measurable physical parameters.
Clinical Evaluation: The "ground truth" for clinical safety and performance is based on real-world patient outcomes and reported incidents/adverse events from existing clinical use and literature reviews.

8. Sample Size for the Training Set

This is not applicable. The Z-MED and Z-MED II are physical medical devices undergoing traditional bench testing and clinical review, not AI models that require training sets.

9. How the Ground Truth for the Training Set Was Established

This is not applicable, as there is no training set for a physical medical device.

Summary

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K122012

ОСТ

4 2012

Appendix D

GOK Summary of Safety & Effectiveness

GeneralProvisions	Trade Name: Z-MED and Z-MED II CathetersClassification Name: Balloon Aortic Valvuloplasty Catheters

Name ofPredicateDevice	NuCLEUS-X Catheter (K082776)NuCLEUS Catheter (K082776)
Classification	Class II, 21 CFR 870.1255
PerformanceStandards	Performance Standards have not been established by FDA under Section 514of the Food, Drug and Cosmetic Act.
Intended Use	Balloon Aortic Valvuloplasty
	Continued on next nage

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Summary of Safety & Effectiveness, Continued

Device The NuMED Z-MED™ catheter is a coaxial catheter recommended for Balloon Description Aortic Valvuloplasty. The catheter's inner and outer shafts are constructed of polyamide tubing. 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. This balloon is of the non-compliant variety. Both the shaft size and the guidewire size vary according to balloon diameter. The distal lumen terminates at the tip of the catheter and will accept the passage of the appropriate guidewire. The lumen has radiopaque platinum marker band(s), centered or under the balloon shoulders, for placement using fluoroscopy. The catheter is white in color and the balloon material is clear. The catheter balloon diameter and name is stamped onto the Y sleeve and the balloon extension is labeled with the catheter specifications and lot number. The catheter is packaged in a polyethylene sheath and is double packed in two heat sealed Tyvek pouches. The NuMED Z-MED II™ catheter is a coaxial catheter recommended for Balloon Aortic Valvuloplasty. The catheter's inner and outer shafts are constructed of polyamide tubing. 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. This balloon is of the non-compliant variety. Both the shaft size and the guidewire size vary according to balloon diameter. The distal lumen terminates at the tip of the catheter and will accept the passage of the appropriate guidewire. The lumen has radiopaque platinum marker band(s), centered or under the balloon shoulders, for placement using fluoroscopy. The catheter is white in color and the balloon material is clear. The catheter balloon diameter and name is stamped onto the Y sleeve and the balloon extension is labeled with the catheter specifications and lot number. The catheter is packaged in a polyethylene sheath and is double packed in two heat sealed Tyvek pouches. Biocompatibility

All materials used to manufacture the Z-MED and Z-MED II Catheters are available on other commercially available NuMED, Inc. devices (K022722, K081680, and K014124) and have passed all relevant biocompatibility tests. No additional biocompatibility testing was conducted for the Z-MED and Z-MED II Catheters.

In-Vitro Testing

In-Vitro testing was completed on the Z-MED and Z-MED II catheters for their original 510(k) submissions (K991977 and K003052). No additional testing was completed for the expanded indication because both indications are for valvuloplasty. A complete list of tests performed and the results are provided in the table below.

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TestPerformed	AcceptanceCriteria	Z-MEDResults	Z-MED IIResults	NuCLEUS-XResults	NuCLEUSResults
VisualInspection	The cathetersshall be free fromcontamination,discoloration, andany form ofdamage that couldimpact the properfunctioning of thedevice.	All catheterswere visuallyinspectedwithout anyanomalies.	All catheterswere visuallyinspected withoutany anomalies.	All catheterswere visuallyinspectedwithout anyanomalies.	All catheterswere visuallyinspected withoutany anomalies.
BalloonPreparation Test	Each cathetershall be preppedper the procedurewithout functionaldifficulties oranomalies.	All catheterstested werewithoutfunctionaldifficulties oranomalies.	All catheterstested werewithoutfunctionaldifficulties oranomalies.	All catheterstested werewithoutfunctionaldifficulties oranomalies.	All catheterstested werewithoutfunctionaldifficulties oranomalies.
Diameter andProfile Test	The balloondiameter at ratedburst pressureshall be within +/- 10% of thelabeled balloondiameter and thesamples should fitthrough theselectedintroducer withno problems.	All catheters metthe acceptancecriteria.	All catheters metthe acceptancecriteria.	All cathetersmet theacceptancecriteria.	All catheters metthe acceptancecriteria.
BalloonDistensibility	The results mustdemonstrate thatthe balloondiameter arewithin +/- 10% ofthe labeleddiameter at theRBP and will notbe significantlyincreased atincreasinglyhigher pressures.	All data obtaineddemonstrates that theballoon diameter iswithin +/- 10% of thelabeled diameter atthe RBP. All dataobtaineddemonstrates that thediameter of theballoons will not besignificantlyincreased atincreasingly higherpressures.	All data obtaineddemonstrates that theballoon diameter iswithin +/- 10% of thelabeled diameter atthe RBP. All dataobtained demonstratesthat the diameter ofthe balloons will notbe significantlyincreased atincreasingly higherpressures.	All data obtaineddemonstrates thatthe balloon diameteris within +/- 10% ofthe labeled diameterat the RBP. All dataobtaineddemonstrates thatthe diameter of theballoons will not besignificantlyincreased atincreasingly higherpressures.	All data obtaineddemonstrates that theballoon diameter iswithin +/- 10% of thelabeled diameter atthe RBP. All dataobtaineddemonstrates that thediameter of theballoons will not besignificantlyincreased atincreasingly higherpressures.
Balloon MinimumBurst Strength	The results mustshow statisticallythat with at least95% confidence,99.9% of theballoons will notburst at or belowthe maximumrecommended	2 x 1 - 10 ATM2 x 1.5 - 10 ATM3mm - 10 ATM4mm - 10 ATM5mm - 10 ATM6mm - 10 ATM7mm - 10 ATM8mm - 10 ATM9mm - 10 ATM10mm - 9 ATM11mm - 7 ATM12mm - 7 ATM	4 x 2 - 15 ATM4 x 6 - 15 ATM4 x 10 - 15 ATM5 x 2 - 15 ATM6 x 2 - 15 ATM7 x 2 - 15 ATM8 x 2 - 15 ATM9 x 2 - 14 ATM10 x 2 - 13 ATM11 x 2 - 10 ATM	18 x 4 - 4 ATM18 x 6 - 4 ATM20 x 4 - 4 ATM22 x 4 - 3 ATM25 x 4 - 3 ATM28 x 4 - 2 ATM30 x 4 - 2 ATM30 x 6 - 2 ATM	10 x 3 - 9 ATM10 x 6 - 9 ATM12 x 4 - 7 ATM14 x 4 - 6 ATM16 x 4 - 5 ATM18 x 4 - 4 ATM20 x 4 - 4 ATM22 x 4 - 3 ATM25 x 4 - 3 ATM28 x 4 - 2 ATM
TestPerformed	AcceptanceCriteria	Z-MEDResults	Z-MED IIResults	NuCLEUS-XResults	NuCLEUSResults

	rated burstpressure.	13mm - 6 ATM14mm - 6 ATM15mm - 5 ATM16mm - 5 ATM17mm - 4 ATM18mm - 4 ATM19mm - 4 ATM20mm - 4 ATM22mm - 3 ATM23mm - 3 ATM24mm - 3 ATM25mm - 3 ATM26mm - 3 ATM28mm - 2 ATM30 x 2 - 2 ATM30 x 6 - 2 ATM33mm - 1.5 ATM35mm - 1.5 ATM40 x 4 - 1 ATM40 x 6 - 1 ATM	12 x 3 - 10 ATM13 x 4 - 10 ATM14 x 3 - 10 ATM15 x 3 - 8 ATM16 x 3 - 8 ATM17 x 4 - 7 ATM18 x 3 - 7 ATM20 x 3 - 5 ATM22 x 3 - 4 ATM23 x 3 - 4 ATM25 x 3 - 4 ATM25 x 6 - 4 ATM26 x 2 - 4 ATM28 x 2 - 3.5 ATM30 x 2 - 3 ATM30 x 6 - 3 ATM30 x 10 - 3 ATM		30 x 4 - 2 ATM30 x 6 - 2 ATM
Repeated BalloonInflation (BalloonFatigue) Test	No breaksallowed	No Breaks.	No Breaks.	No Breaks.	No Breaks.
BalloonInflation/DeflationTest	Inflation achievedin less than 12seconds anddeflation achievedin less than 20seconds	All catheters metthe establishedacceptancecriteria.	All catheters metthe establishedacceptancecriteria.	All cathetersmet theestablishedacceptancecriteria.	All catheters metthe establishedacceptancecriteria.
BalloonDeflatability Test	There should beno interferencewith balloondeflation	All catheters metthe establishedacceptancecriteria.	All catheters metthe establishedacceptancecriteria.	All cathetersmet theestablishedacceptancecriteria.	All catheters metthe establishedacceptancecriteria.
Tip Pull andTorque Test	Must withstand atleast 10 turnswithout breaking	No breaks	No breaks	No breaks	No breaks
Bond StrengthTest	All bonds mustwithstand at least3 lbs. of pullstrength.	All bonds metthe establishedacceptancecriteria.	All bonds met theestablishedacceptancecriteria.	All bonds metthe establishedacceptancecriteria.	All bonds metthe establishedacceptancecriteria.
Catheter BodyMaximumPressure Test	All samples mustwithstand 30ATM (400psi).	>30 ATM	>30 ATM	>30 ATM	>30 ATM

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In Vivo A Clinical Evaluation Report was prepared for the Z-MED and Z-MED II Evaluation Catheters for this new indication of balloon aortic valvuloplasty (BAV). This Clinical Evaluation Report was compiled to meet the requirements of the Medical Device Directive MOD 93/42/EEC, as amended, and establish the safety and performance of the device, as well as a review of Clinical Literature. The report also includes the history of the device, previous sales and complaints reported.

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The information included in the 2012 clinical evaluation report also describes the clinical use of the Z-MED and Z-MED II catheters in those countries where they are used in balloon aortic valvuloplasty (BAV) and balloon mitral valvuloplasty (BMV), as well as for balloon pulmonary valvuloplasty (BPV) here in the United States. Numerous clinical studies reported in literature for Transcutaneous Aortic Valve Implant (TAVI) replacement surgery reference the use of the Z-MED and Z-MED II catheters for BAV prior to TAVI (over 200 patients) without incidents or adverse events.

The totality of this information provides further validation for the use of the Z-MED and Z-MED II catheters for balloon aortic valvuloplasty.

Summary of Safety and Effectiveness

The NuCLEUS-X Catheter has been tested and compared to the predicate devices listed herein. All data gathered demonstrate the NuCLEUS-X Catheter is substantially equivalent. No new issues of safety or efficacy have been raised.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT
4 2012

NuMED, Inc. c/o Mr. Nichelle LaFlesh Regulatory Affairs Manager/Compliance Officer 2880 Main Street Hopkinton, NY 12965

Re: K122012 Z-MED and Z-MED II Catheters Regulation Number: 21 CFR 870.1255 Regulation Name: Balloon Aortic Valvuloplasty Catheters Regulatory Class: Class II Product Code: OZT Dated: July 9, 2012 Received: July 10, 2012

Dear Mr. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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Page 2 - Mr. Nichelle LaFlesh

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

MA Hillen

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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Appendix E

Indications for Use

KI22012 510(k) Number (if known):

Device Name: Z-MED and Z-MED II Catheters

Indications For Use:

Balloon Aortic Valvuloplasty

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)

C.M.A. Hilliker

ivision Sign-Off) Division of Cardiovascular Devices

510(k) Number K122012

Page 1 of 1

Regulation Number and Section

§ 870.1255 Balloon aortic valvuloplasty catheter.

(a)
Identification. A balloon aortic valvuloplasty catheter is a catheter with a balloon at the distal end of the shaft, which is intended to treat stenosis in the aortic valve when the balloon is expanded.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible.
(2) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components.
(3) Non-clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use, including device delivery, inflation, deflation, and removal.
(4) In vivo evaluation of the device must demonstrate device performance, including the ability of the device to treat aortic stenosis.
(5) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to the use of the device.