(86 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a catheter with a balloon specifically designed and recommended for "Balloon Aortic Valvuloplasty," which is a medical procedure to treat a condition and restore valve function.
No
Explanation: The device is a coaxial catheter explicitly recommended for Balloon Aortic Valvuloplasty, which is a therapeutic procedure rather than a diagnostic one. Its purpose is to perform an intervention, not to diagnose a condition.
No
The device description clearly details a physical catheter with a balloon, shafts, lumens, and radiopaque markers, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Balloon Aortic Valvuloplasty," which is a surgical procedure performed in vivo (within the living body) to treat a heart valve condition.
- Device Description: The description details a catheter with a balloon designed for mechanical intervention within the body.
- Mechanism of Action: The device works by physically expanding a balloon within the aortic valve to widen it. This is a mechanical action, not a diagnostic test performed on a sample in vitro (outside the living body).
- Performance Studies: The performance studies focus on the physical properties and clinical performance of the device during the procedure, not on the accuracy of a diagnostic test.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform such a function.
N/A
Intended Use / Indications for Use
Balloon Aortic Valvuloplasty
Product codes
OZT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Aortic
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:
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.
Tests Performed and Key Results:
- Visual Inspection: All catheters were visually inspected without any anomalies.
- Balloon Preparation Test: All catheters tested were without functional difficulties or anomalies.
- Diameter and Profile Test: All catheters met the acceptance criteria (balloon diameter at rated burst pressure within +/- 10% of labeled diameter and fit through selected introducer).
- Balloon Distensibility: All data obtained demonstrates that the balloon diameter is within +/- 10% of the labeled diameter at the RBP and will not be significantly increased at increasingly higher pressures.
- Balloon Minimum Burst Strength: Various burst pressures were measured for different balloon sizes, demonstrating that the balloons will not burst at or below the maximum recommended rated burst pressure with at least 95% confidence for 99.9% of the balloons.
- Repeated Balloon Inflation (Balloon Fatigue) Test: No Breaks.
- Balloon Inflation/Deflation Test: All catheters met the established acceptance criteria (inflation in less than 12 seconds and deflation in less than 20 seconds).
- Balloon Deflatability Test: All catheters met the established acceptance criteria (no interference with balloon deflation).
- Tip Pull and Torque Test: No breaks.
- Bond Strength Test: All bonds met the established acceptance criteria (withstand at least 3 lbs. of pull strength).
- Catheter Body Maximum Pressure Test: All samples withstood >30 ATM (400psi).
In Vivo Evaluation:
A Clinical Evaluation Report was prepared for the Z-MED and Z-MED II Catheters for this new indication of balloon aortic valvuloplasty (BAV). This 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. The 2012 clinical evaluation report describes the clinical use of the Z-MED and Z-MED II catheters in countries where they are used in balloon aortic valvuloplasty (BAV) and balloon mitral valvuloplasty (BMV), as well as for balloon pulmonary valvuloplasty (BPV) 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
NuCLEUS-X Catheter (K082776), NuCLEUS Catheter (K082776)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
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