(49 days)
Cordis OPTA™ PRO Balloon Dilatation Catheter
Not Found
No
The provided text describes a standard balloon dilatation catheter and its physical characteristics. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The device is intended to treat and dilate stenoses and obstructive lesions in various arteries and fistulae, which are therapeutic actions.
No
The device is described as a "Balloon Dilatation Catheter" intended "to dilate stenoses," which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly details a physical catheter with a balloon, lumens, radiopaque markers, and a tapered tip, indicating it is a hardware medical device.
Based on the provided information, the SAILOR™ PLUS PTA Balloon Dilatation Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a device used within the body to dilate blood vessels and treat lesions. This is an in vivo procedure.
- Device Description: The description details a catheter with a balloon designed for insertion into the circulatory system. This is consistent with an in vivo device.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health. The SAILOR PLUS does not perform this function.
Therefore, the SAILOR™ PLUS PTA Balloon Dilatation Catheter is a medical device used for therapeutic intervention within the body, not an IVD.
N/A
Intended Use / Indications for Use
The SAILOR PLUS PTA 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 (comma separated list FDA assigned to the subject device)
LIT, DQY
Device Description
The SAILOR PLUS Balloon Dilatation Catheter is OTW PTA catheter with a semi-compliant inflatable balloon mounted at the distal tip. It has a dual lumen catheter with a guidewire lumen and a balloon inflation lumen. Two radiopaque markers indicate the dilating portion of the balloon and help in correctly positioning the balloon within the vessel. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses. The maximum recommended guidewire diameter is 0.035". The device is available in balloon diameters of 3-12mm, balloon lengths of 20, 40, 60, 80 and 120mm and catheter lengths of 130. 80 and 40cm.
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, and for the treatment of obstructive lesions of native or synthetic 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 SAILOR 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 OPTA™ PRO 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
K042538
page 1 of 2
510(k) Summary SAILOR 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 | SAILOR 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 OPTA™ PRO Balloon Dilatation Catheter |
| Intended use | The SAILOR PLUS PTA 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. |
| Device Description | The SAILOR PLUS Balloon Dilatation Catheter is OTW PTА
catheter with a semi-compliant inflatable balloon mounted at the
distal tip. It has a dual lumen catheter with a guidewire lumen and
a balloon inflation lumen. Two radiopaque markers indicate the
dilating portion of the balloon and help in correctly positioning the
balloon within the vessel. The catheter tip is tapered to ease entry
into peripheral arteries and to facilitate the crossing of tight
stenoses. The maximum recommended guidewire diameter is
0.035". The device is available in balloon diameters of 3-12mm,
balloon lengths of 20, 40, 60, 80 and 120mm and catheter lengths
of 130. 80 and 40cm |
| Biocompatibility | All material used in SAILOR 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 SAILOR 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 SAILOR PLUS Balloon Dilatation Catheter is similar to the
predicate with respect to intended use and to physical
characteristics, such as catheter and balloon dimensions and catheter
design and materials. Further, the mechanical and biocompatibility
testing data is indicative of the safety and effectiveness of SAILOR
PLUS Balloon Dilatation Catheter. |
| Conclusion | SAILOR PLUS Balloon Dilatation Catheter is substantially
equivalent to the Predicate device |
| Sailor Plus PTA Balloon Dilatation Catheter Traditional 510(k)
510(k) Summary
1
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·
04533
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the 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: K042538
K042336
SAILOR PLUS™ 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 indication We have reviewed your Section J I (t), I premaint is substantially equivalent (for the indications
referenced above and have determined the device is substantially equivaled referenced above and nave detenmitted the devices marketed in interstate for use stated in the enclosure) to tegally inanced to the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food. Drug. commerce prior to May 28, 1976, the enactinent and or or the Federal Food. Drug, devices that have been reclassified in accordance who areas approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The Act. The You may, therefore, market the device, subject to the gents for annual registration, listing of
general controls provisions of the Act include required whileities anainet mis general controls provisions of the Act morade requirement.
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 aove) mits chass in expendsions affecting your device can
may be subject to such additional controls. Existing major regulations allection, may be subject to such adultional controlis: Extrems, "And to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 Register be found in the Code of Federal Regarations, 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 Ticase oc advised that I Dr Pressunt to syour device complies with other requirements of the Act that I Dri has made a sond regulations administered by other Federal agencies. You must or any I cacal statutes and regainents and limited to: registration and listing (21 Comply with an the Act 8 requirements) (1); good manufacturing practice requirements as set CFR Part 6077, adoning (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product including on to begin marketing your device as described in your Section 510(k) rms letter will and w you've obgen finding of substantial equivalence of your device to a legally promative noticate 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 desire spocific ac ripliance 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 sales and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
(2017-15-05) fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Blummenfor
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:
Device Name: SAILOR™ PLUS PTA Balloon Dilatation Catheter
Indications For Use:
The SAILOR™ PLUS PTA 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 V (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)
Bhummmmar
(Division Sign Off)
(Division Sign-Off) Division of Cardlovascular Devices 510fk) Number KO *
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