Who is the manufacturer of Z-MED Z-MED II?

NuMED, Inc. filed the 510(k) submission for Z-MED Z-MED II (K122012).

What is the FDA product code for Z-MED Z-MED II?

OZT. It is classified under 21 CFR 870.1255 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Z-MED Z-MED II?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Z-MED Z-MED II?

NuCLEUS-X Catheter (K082776); NuCLEUS Catheter (K082776).

Who can help prepare an FDA 510(k) submission like Z-MED Z-MED II?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Z-MED Z-MED II

K122012 · NuMED, Inc. · OZT · Oct 4, 2012 · Cardiovascular

Device Facts

Record ID	K122012
Device Name	Z-MED Z-MED II
Applicant	NuMED, Inc.
Product Code	OZT · Cardiovascular
Decision Date	Oct 4, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1255
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Balloon Aortic Valvuloplasty

Device Story

Z-MED and Z-MED II are coaxial catheters for balloon aortic valvuloplasty. Device features polyamide inner/outer shafts and a non-compliant polyamide balloon. Radiopaque platinum marker bands facilitate placement via fluoroscopy. Operated by physicians in clinical settings. Catheter is inserted over a guidewire; balloon is inflated to dilate the stenotic aortic valve. Output is mechanical dilation of the valve. Benefits include improved valve function and preparation for transcutaneous aortic valve implantation (TAVI).

Clinical Evidence

No new clinical trials conducted. Evidence includes a clinical evaluation report per MDD 93/42/EEC, literature review, and historical sales/complaint data. Literature references use of Z-MED/Z-MED II in over 200 patients for BAV prior to TAVI without adverse events. Bench testing provided for all performance parameters.

Technological Characteristics

Coaxial catheter design; polyamide tubing shafts; non-compliant polyamide balloon; radiopaque platinum marker bands. Dimensions/shaft size vary by balloon diameter. Sterilized via standard methods (implied by Tyvek packaging). No electronic components or software.

Indications for Use

Indicated for balloon aortic valvuloplasty in patients requiring treatment for aortic valve stenosis.

Regulatory Classification

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.

Special Controls

*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.

In combination with the general controls of the FD&C Act, the NuMED NuCLEUS and NuCLEUS-X BAV Catheters are subject to the following special controls:

Predicate Devices

NuCLEUS-X Catheter (K082776)
NuCLEUS Catheter (K082776)

Related Devices

DEN080015 — NUCLEUS-X PTV CATHETER · NuMED, Inc. · Jun 11, 2012
K991977 — TYSHAK, MODEL 102 AND Z-MED, MODEL 302 · NuMED, Inc. · Sep 27, 2000
K121083 — TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA · Loma Vista Medical · Oct 11, 2012
K260437 — Valvuloplasty Balloon Catheter (ValvuloPro) · Dongguan TT Medical, Inc. · Mar 20, 2026
K133569 — TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM · Bard Peripheral Vascular, Inc. · Dec 20, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ K122012 ОСТ 4 2012 # Appendix D # GOK Summary of Safety & Effectiveness | General Provisions | Trade Name: Z-MED and Z-MED II Catheters Classification Name: Balloon Aortic Valvuloplasty Catheters | | | | | | |--------------------------------|-----------------------------------------------------------------------------------------------------------------|--|--|--|--|--| | | | | | | | | | Name of Predicate Device | NuCLEUS-X Catheter (K082776) NuCLEUS Catheter (K082776) | | | | | | | Classification | Class II, 21 CFR 870.1255 | | | | | | | Performance Standards | Performance Standards have not been established by FDA under Section 514 of the Food, Drug and Cosmetic Act. | | | | | | | Intended Use | Balloon Aortic Valvuloplasty | | | | | | | | Continued on next nage | | | | | | {1}------------------------------------------------ ### 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. {2}------------------------------------------------ | Test Performed | Acceptance Criteria | Z-MED Results | Z-MED II Results | NuCLEUS-X Results | NuCLEUS 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. | 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. | 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. | All catheters met the acceptance criteria. | All catheters met the acceptance criteria. | | Balloon Distensibility | The results must demonstrate that the balloon diameter are 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. | 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 | 2 x 1 - 10 ATM 2 x 1.5 - 10 ATM 3mm - 10 ATM 4mm - 10 ATM 5mm - 10 ATM 6mm - 10 ATM 7mm - 10 ATM 8mm - 10 ATM 9mm - 10 ATM 10mm - 9 ATM 11mm - 7 ATM 12mm - 7 ATM | 4 x 2 - 15 ATM 4 x 6 - 15 ATM 4 x 10 - 15 ATM 5 x 2 - 15 ATM 6 x 2 - 15 ATM 7 x 2 - 15 ATM 8 x 2 - 15 ATM 9 x 2 - 14 ATM 10 x 2 - 13 ATM 11 x 2 - 10 ATM | 18 x 4 - 4 ATM 18 x 6 - 4 ATM 20 x 4 - 4 ATM 22 x 4 - 3 ATM 25 x 4 - 3 ATM 28 x 4 - 2 ATM 30 x 4 - 2 ATM 30 x 6 - 2 ATM | 10 x 3 - 9 ATM 10 x 6 - 9 ATM 12 x 4 - 7 ATM 14 x 4 - 6 ATM 16 x 4 - 5 ATM 18 x 4 - 4 ATM 20 x 4 - 4 ATM 22 x 4 - 3 ATM 25 x 4 - 3 ATM 28 x 4 - 2 ATM | | Test Performed | Acceptance Criteria | Z-MED Results | Z-MED II Results | NuCLEUS-X Results | NuCLEUS Results | | | | | | | | | | rated burst pressure. | 13mm - 6 ATM 14mm - 6 ATM 15mm - 5 ATM 16mm - 5 ATM 17mm - 4 ATM 18mm - 4 ATM 19mm - 4 ATM 20mm - 4 ATM 22mm - 3 ATM 23mm - 3 ATM 24mm - 3 ATM 25mm - 3 ATM 26mm - 3 ATM 28mm - 2 ATM 30 x 2 - 2 ATM 30 x 6 - 2 ATM 33mm - 1.5 ATM 35mm - 1.5 ATM 40 x 4 - 1 ATM 40 x 6 - 1 ATM | 12 x 3 - 10 ATM 13 x 4 - 10 ATM 14 x 3 - 10 ATM 15 x 3 - 8 ATM 16 x 3 - 8 ATM 17 x 4 - 7 ATM 18 x 3 - 7 ATM 20 x 3 - 5 ATM 22 x 3 - 4 ATM 23 x 3 - 4 ATM 25 x 3 - 4 ATM 25 x 6 - 4 ATM 26 x 2 - 4 ATM 28 x 2 - 3.5 ATM 30 x 2 - 3 ATM 30 x 6 - 3 ATM 30 x 10 - 3 ATM | | 30 x 4 - 2 ATM 30 x 6 - 2 ATM | | Repeated Balloon Inflation (Balloon Fatigue) Test | No breaks allowed | No Breaks. | No Breaks. | 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. | 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. | 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 | 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. | 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 | >30 ATM | >30 ATM | . · {3}------------------------------------------------ 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. {4}------------------------------------------------ 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. {5}------------------------------------------------ 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 {6}------------------------------------------------ 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 {7}------------------------------------------------ ## 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