(49 days)
Not Found
Not Found
No
The device description and performance studies focus on the mechanical properties and function of a balloon catheter, with no mention of AI or ML.
Yes
The device is intended to dilate stenoses and treat obstructive lesions, which are therapeutic interventions.
No
This device is a therapeutic device used for dilating stenoses, not for diagnosing them. It is a balloon dilatation catheter used for treatment purposes.
No
The device description clearly details a physical catheter with a balloon, lumens, and radiopaque markers, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The SUBMARINE™ PLUS Balloon Dilatation Catheter is a device used inside the body to physically dilate narrowed arteries and fistulae. It is a therapeutic device, not a diagnostic one. It doesn't analyze samples or provide diagnostic information based on laboratory tests.
The description clearly indicates it's a catheter with a balloon for mechanical intervention within the vascular system.
N/A
Intended Use / Indications for Use
The SUBMARINE PLUS Balloon Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The SUBMARINE™ PLUS Balloon Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Product codes
LIT, DQY
Device Description
The SUBMARINE PLUS Balloon Dilatation Catheter is a catheter with a semi-compliant inflatable balloon mounted at the distal tip. It has a coaxial lumen. The central lumen of the catheter, which terminates at the distal tip, is used to pass the catheter over a guidewire with a maximum outer diameter of 0.018 inch (0.45 mm). The other lumen is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. The catheter tapers beneath the balloon segment to achieve the lowest possible deflated profile. Two radiopaque marker bands are placed under the balloon segment of the catheter shaft to provide visual reference points for balloon positioning within the vessel. The distal catheter shaft is hydrophilic coated (balloon excluded). The SUBMARINE PLUS Balloon Dilatation Catheter is available in different balloon sizes (balloon diameters of 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 and 7.0mm and balloon lengths of 20, 40, 60, 80 and 120mm). Nominal balloon diameter and length are printed on the hub. The maximum recommended guidewire diameter is 0.018" and the usable catheter length is 130 or 90 cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, arteriovenous dialysis fistulae
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)
In vitro testing was conducted to demonstrate the safety and effectiveness of SUBMARINE PLUS Percutaneous Transluminal Angioplasty (PTA) Catheter. The testing included balloon compliance, balloon burst pressure, balloon fatigue, shaft burst pressure, bond strength, catheter dimensions and guidewire and introducer compatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Cordis SAVVY™ Balloon Dilatation Catheter
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
K042537
page 1 of 2
510(k) Summary
SUBMARINE PLUS Percutaneous Transluminal Angioplasty (PTA) Catheter
| 510(k) Summary | This summary of 510(k) safety and effectiveness information is
being submitted in accordance with the requirements of 21 C.F.R §
807.92. |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant
(Manufacturer) | Invatec Innovative Technologies
Via Martiri della Libertà, 7
25030 Roncadelle (BS) Italy
Tel: +39 030 258 93 11
Fax: +39 030 258 93 12
www.invatec.com
info@invatec.com |
| Submitter | ev3 Inc.
4600 Nathan Lane North
Plymouth, MN 55442
Tel: (763) 398 7000
Fax: (763) 398 7200 |
| Contact Person | Mike Winegar
Tel: (763) 398-7225
Fax: (763) 398-7200
E-mail: mwinegar@ev3.net |
| Date Prepared | September 17th, 2004 |
| Device Trade Name | SUBMARINE PLUS Percutaneous Transluminal Angioplasty
(PTA) Catheter |
| Device Common Name | Peripheral Transluminal Angioplasty (PTA) Catheter |
| Classification Name | 21 CFR 870.1250 Percutaneous Catheter |
| Device Classification | Regulatory Class: Class II
Product Code: LIT |
| Classification Panel | Cardiovascular |
| Predicate Device | Cordis SAVVY™ Balloon Dilatation Catheter |
| Intended use | The SUBMARINE PLUS Balloon Dilatation Catheter is intended to
dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra
popliteal, renal arteries and for the treatment of obstructive lesions
of native or synthetic arteriovenous dialysis fistulae. |
| Device Description | The SUBMARINE PLUS Balloon Dilatation Catheter is a catheter
with a semi-compliant inflatable balloon mounted at the distal tip.
It has a coaxial lumen. The central lumen of the catheter, which
terminates at the distal tip, is used to pass the catheter over a
guidewire with a maximum outer diameter of 0.018 inch (0.45 mm).
The other lumen is the balloon inflation lumen, which is used to
inflate and deflate the dilatation balloon with a mixture of contrast
medium and saline solution. The catheter tapers beneath the balloon
segment to achieve the lowest possible deflated profile. Two
radiopaque marker bands are placed under the balloon segment of
the catheter shaft to provide visual reference points for balloon |
| page dot d | |
| | positioning within the vessel. The distal catheter shaft is hydrophilic
coated (balloon excluded). The SUBMARINE PLUS Balloon
Dilatation Catheter is available in different balloon sizes (balloon
diameters of 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 and 7.0mm and
balloon lengths of 20, 40, 60, 80 and 120mm). Nominal balloon
diameter and length are printed on the hub. The maximum
recommended guidewire diameter is 0.018" and the usable catheter
length is 130 or 90 cm. |
| Biocompatibility | All material used in SUBMARINE PLUS Percutaneous
Transluminal Angioplasty (PTA) Catheter are biocompatible based
on the biocompatibility testing. |
| Performance data | In vitro testing was conducted to demonstrate the safety and
effectiveness of SUBMARINE PLUS Percutaneous Transluminal
Angioplasty (PTA) Catheter. The testing included balloon
compliance, balloon burst pressure, balloon fatigue, shaft burst
pressure, bond strength, catheter dimensions and guidewire and
introducer compatibility. |
| Summary of Substantial
Equivalence | The SUBMARINEPLUS Balloon Dilatation Catheter is similar to
the predicate with respect to the intended use, and with respect to
their physical characteristics, such the catheter and balloon
dimensions and catheter design and material. SAILOR PLUS
Balloon Dilatation Catheter is therefore substantially equivalent to
the Predicate device. Further, the mechanical and biocompatibility
testing data is indicative of the safety and effectiveness of
SUBMARINE PLUS Balloon Dilatation Catheter. Therefore based
on its own performance characteristics and the technological
similarities, SUBMARINE PLUS Balloon Dilatation Catheter is
expected to perform similar to the predicate device and other
comparable, currently marketed PTA catheters. |
| Conclusion | SUBMARINE PLUS Balloon Dilatation Catheter is substantially
equivalent to the Predicate device and other currently marketed PTA
catheters. |
Submarine Plus OTW PTA Balloon Catheter
Traditional 510(k) 510(k) Summary
1
.
·
2
Image /page/2/Picture/2 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 8 2004
Invatec Innovative Technologies c/o Mr. Mike Winegar Vice President, International RA ev3 Inc. 4600 Nathan Lane North Plymouth, MN 55442
Re: K042537
KU42337
SUBMARNE PLUSTM Percutaneous Transluminal Angioplasty (PTA) Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: September 17, 2004 Received: September 20, 2004
Dear Mr. Winegar:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) premained in the tabstantially equivalent (for the indications
referenced above and have determined the device is substantial in intersta referenced above and nave declinined the arrased predicate devices marketed in interstate for use stated in the enclosure) to regally manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment at the Federal Food. Dou commerce prior to May 28, 1970, the chactinent and of the Federal Food. Drug, devices that have been recults in accordance with as proval application (PMA).
and Cosmetic Act (Act) that do not require approval assesses approvisions of the Act. The and Cosmetic Act (Act) that do not require approval or a provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of the You may, therefore, market the device, subject to the gentlation annual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act morate requirements.
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 If your device is classified (see above) mo exisi crows in trepulations affecting your device can
may be subject to such additional controls. Tim may be subject to such additions. Laisung major regal to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. be found in the Code of Pederal Regaraters, concerning your device in the Federal Register.
3
Page 2 - Mr. Mike Winegar
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be deviloed alla i termination that your device complies with other requirements of the Act that I Dri has made a active and regulations administered by other Federal agencies. You must or uny I cather 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 CFK in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in also quarty 25 cool provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product including in begin marketing your device as described in your Section 510(k) This icter will anow you to begin inding of substantial equivalence of your device to a legally promaticated 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 If you docure of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bhimmer for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: K04 2537
Device Name: SUBMARINE™ PLUS PTA Balloon Dilatation Catheter
Indications For Use:
The SUBMARINE™ PLUS Balloon Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Prescription Use (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)
Blommor
Sivision Sign-Off) Division of Cardiovascular Devices 510(k) Number_
Page I of
Submarine Plus PTA Balloon Catheter Traditional 510(k) 510(k) Body