(24 days)
No
The device description focuses on the physical components and function of a sizing balloon catheter, with no mention of software, algorithms, or AI/ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is used for accurate measurement of defects to select an appropriately sized occluder device, not to treat or cure a condition.
No
The device is described as a "Sizing Balloon catheter" used for "accurate measurement of the defect is important to select the appropriately sized occluder device." Its purpose is to measure a defect, not to diagnose a condition.
No
The device description clearly details a physical catheter with a balloon, lumens, marker bands, and packaging, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is a "Sizing Balloon catheter" used for "accurate measurement of the defect" within the cardiovascular system in vivo (inside the body). It is used in conjunction with fluoroscopy, an imaging technique.
- No Specimen Analysis: There is no mention of the device analyzing any biological specimens taken from the patient.
The device is an invasive medical device used for diagnostic and procedural purposes within the cardiovascular system.
N/A
Intended Use / Indications for Use
For use in those patients with cardiovascular defects wherein accurate measurement . I of the defect is important to select the appropriately sized occluder device.
Product codes
MJN
Device Description
The NuMED, Inc. PTS X™ Sizing Balloon catheter is a coaxial catheter for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device. The outer body is made of polymeric tubing, and the inner tubing is comprised of a multi layer extrusion of polyamide (Vestamid PA12) that surrounds a braid of 304 LV Stainless Steel. The catheter features a proximal end bifurcate with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon. This balloon is of the non-compliant variety and will have a typical single wall thickness of 0.0004". This balloon is designed to insert through the smallest possible introduction sleeve. The through lumen terminates at the tip of the catheter and will accept the passage of the appropriate guidewire. This lumen has radiopaque platinum marker bands under the balloon shoulders for placement using fluoroscopy. Additionally, there are two radiopaque platinum marker bands spaced at 10mm (as measured from leading edge to leading edge). These bands are located at the balloon center and are used as a distance reference. The catheter is white in color and the balloon material is clear. 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 loop 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
fluoroscopy
Anatomical Site
cardiovascular
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 Testing: The materials used in the NuMED PTS X Catheter are the same as those used in our other PTA Catheters (510(k) #K931009) and PTV Catheters (510(k) #K991977) which were tested for biocompatibility in compliance with the Tripartite Biocompatibility Guidance for Medical Devices. There have been no changes in material from the original PTS approval (K003320) except for the change to the inner tubing. The inner tubing has already been use in our other catheters and has been approved through 510(k) #022722. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
NuMED PTS Catheter
Reference Device(s)
510(k) #K931009, 510(k) #K991977, K003320, 510(k) #022722
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
May 14, 2004
Submitted By: NuMED, Inc., 2880 Main St., Hopkinton, NY 12965 (Ph) 315-328-4491
Contact Person: Nichelle LaFlesh
Device Name: NuMED PTS X Catheter
Predicate Devices: NuMED PTS Catheter
Device Description: The NuMED, Inc. PTS X™ Sizing Balloon catheter is a coaxial catheter for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device. The outer body is made of polymeric tubing, and the inner tubing is comprised of a multi layer extrusion of polyamide (Vestamid PA12) that surrounds a braid of 304 LV Stainless Steel. The catheter features a proximal end bifurcate with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon. This balloon is of the non-compliant variety and will have a typical single wall thickness of 0.0004". This balloon is designed to insert through the smallest possible introduction sleeve. The through lumen terminates at the tip of the catheter and will accept the passage of the appropriate guidewire. This lumen has radiopaque platinum marker bands under the balloon shoulders for placement using fluoroscopy. Additionally, there are two radiopaque platinum marker bands spaced at 10mm (as measured from leading edge to leading edge). These bands are located at the balloon center and are used as a distance reference. The catheter is white in color and the balloon material is clear. 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 loop and is double packed in two heat sealed Tyvek pouches.
Biocompatibility Testing: The materials used in the NuMED PTS X Catheter are the same as those used in our other PTA Catheters (510(k) #K931009) and PTV Catheters (510(k) #K991977) which were tested for biocompatibility in compliance with the Tripartite Biocompatibility Guidance for Medical Devices. There have been no changes in material from the original PTS approval (K003320) except for the change to the inner tubing. The inner tubing has already been use in our other catheters and has been approved through 510(k) #022722. 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: For use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device.
1
Image /page/1/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird with three stylized wing segments.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 0 2004
NuMED Inc. c/o Ms. Nichelle LaFlesh Regulatory Affairs Manager 2880 Main Street Hopkinton, NY 12965
Re: K041306
NuMED PTS X Sizing Balloon Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Catheter, Intravascular Occluding, Temporary Regulatory Class: Class II (two) Product Code: MJN Dated: May 14, 2004 Received: May 17, 2004
Dear Ms. LaFlesh:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the endrobars) is regions and ment date of the Medical Device Amendments, or to conninered processified in accordance with the provisions of the Federal Food, Drug, de vices that have been rechasined in quire approval of a premarket approval application (PMA). alla Costience Act (710) that do november to the general controls provisions of the Act. The I ou may, dicrerere, maines of the Act include requirements for annual registration, listing of general controls provisions of uactice, 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 If your device is classified (600 a00 10) the existing major regulations affecting your device can may be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 – Ms. Nichelle LaFlesh
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease of advised that I DTT 3 155 and 10 vice complies with other requirements of the Act that I DA has made a downlations administered by other Federal agencies. You must of any I edical statutes and regulations and limited to: registration and listing (21 Comply with an the Fee 310 cart 801); good manufacturing practice requirements as set CFK Fat 607), laboring (21 OF RT Rat 807), good if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (weeting your device as described in your Section 510(k) This leter will unow you to organization of substantial equivalence of your device to a legally premaired predicated on: "The 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 If you desire specific at (301) 594-4648. Also, please note the regulation entitled, Connation of Comptains and (set notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small outer general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
(501) + / / www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Dung R. Lochner
(JA Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K041306
Device Name: PTS X Catheter
Indications For Use:
- For use in those patients with cardiovascular defects wherein accurate measurement . I of the defect is important to select the appropriately sized occluder device.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)
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)
Duane P. Schunel
Cantiovascula: Devices
306 ---------510(k) Numbe
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