(223 days)
Not Found
No
The device description details a purely mechanical retrieval system using a nitinol wire snare. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
Explanation: The device is intended for the percutaneous retrieval of foreign objects from the body, which is a therapeutic intervention.
No
The device is described as a "grasping device" intended for the retrieval of foreign objects, not for diagnosing conditions. Its function is purely interventional/therapeutic.
No
The device description clearly details physical components such as a PTFE sheath, nitinol wire, stainless steel sleeves, and a plunger, indicating it is a physical 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 clearly describes a device used for the percutaneous retrieval of foreign objects within the body. This is an interventional procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical grasping device designed to be inserted into the body to retrieve objects. This is consistent with a surgical or interventional tool, not a device used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing chemical or biological tests, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens obtained from the human body for the purpose of providing information for diagnosis, monitoring, or screening. This device operates in vivo (within the body) for retrieval purposes.
N/A
Intended Use / Indications for Use
The Needle's Eye Snare® Retrieval Set – 54cm is intended for use in patients requiring the percutaneous retrieval of indwelling catheters, cardiac leads, fragments of catheter tubing or wire guides and other foreign objects.
Product codes (comma separated list FDA assigned to the subject device)
DXE
Device Description
The Needle's Eye Snare® Retrieval Set- 54cm is a grasping device that forms a basketlike snare around the in-dwelling catheter, cardiac lead, fragment of catheter tubing, wire guide or other foreign object. The distal end is delivered to the vicinity of the lead through a long, flexible 12Fr. (O.D.) PTFE sheath placed coaxially within a 16Fr. (O.D.) PTFE Check-Flo® Introducer Sheath having a Check-Flo® Valve with stopcock at its proximal end. The device is comprised at the distal end of a nitinol wire needle's eye retrieval mechanism consisting of a "needle's eye" loop and "threader" with stainless steel sleeves housed within a PTFE protective cover sheath. The snare is activated through the forward advancement of the threader by fully depressing the plunger. The item is captured between the threader and needle's eye. The inner sheath is advanced forward closing the snare and securely capturing the lead or other foreign object. The Needle's Eye Snare® Retrieval Set - 54cm has nominal usable length of 54cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Particulate Testing - Testing was performed to show that particulates from the device are comparable to the predicate and meet the requirements of USP 778. The predetermined acceptance criteria were met.
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.
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
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, layered on top of each other, with flowing lines beneath them.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 11, 2017
Cook Incorporated Thomas Kardos Vice President, Regulatory Affairs 750 Daniels Way, P.O. Box 489 Bloomington, Indiana 47402
Re: K163353
Trade/Device Name: Needle's Eye Snare Retrieval Set - 54cm Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: June 13, 2017 Received: June 14, 2017
Dear Thomas Kardos:
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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerelv.
M.A. Willemsen
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K163353
Device Name
Needle's Eye Snare® Retrieval Set - 54 cm
Indications for Use (Describe)
The Needle's Eye Snare® Retrieval Set - 54cm is intended for use in patients requiring the percutaneous retrieval of indwelling catheters, cardiac leads, fragments of catheter tubing or wire guides and other foreign objects.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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COOK INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A.
PHONE: 812.339.2235 TOLL FREE: 800.457.4500
K163353 Page 1 of 2
510(k) SUMMARY
K163353 510(k) Number: Submitted By: Thomas J. Kardos Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 Phone: (724) 845-8621 x2225 Fax: (724) 845-2848
Date Prepared: July 7, 2017
Device:
| Trade Name: | Needle's Eye Snare® Retrieval Set - 54cm |
|---|---|
| Common Name: | Snare |
| Classification Name: | Embolectomy Catheter |
| DXE (21 CFR 870.5150) | |
| Class/Panel: | Class II, Cardiovascular |
Indications for Use:
The Needle's Eye Snare® Retrieval Set – 54cm is intended for use in patients requiring the percutaneous retrieval of indwelling catheters, cardiac leads, fragments of catheter tubing or wire guides and other foreign objects.
Predicate Device:
The devices, subject of this submission, are substantially equivalent to the predicate devices, the Needle's Eye Snare®, cleared on December 27, 1996 under 510(k) number K961992.
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Image /page/4/Picture/0 description: The image shows the Cook Medical logo. The logo consists of the word "COOK" in large, bold, white letters on a red background. Below the word "COOK" is the word "MEDICAL" in smaller, white letters, also on a red background. The logo is simple and clean, with a focus on the company name.
COOK INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTOΝ, ΙΝ 47402-0489 U.S.A.
NE: 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM
Page 2 of 2
Comparison to Predicate Device:
It has been demonstrated that the Needle's Eye Snare® Retrieval Set - 54cm is comparable to the predicate device, the Needle's Eye Snare® (K961992) is identical in terms of intended use, principles of operation, and basic technological characteristics to the predicate devices, and also identical in materials of construction to the predicate device. The only differences between the predicate and subject device are the specified length of the proposed device, which is 54cm versus the cleared device length of 94cm, and the inclusion of a 12 Fr Curved Inner Sheath as an accessory.
Device Description:
The Needle's Eye Snare® Retrieval Set- 54cm is a grasping device that forms a basketlike snare around the in-dwelling catheter, cardiac lead, fragment of catheter tubing, wire guide or other foreign object. The distal end is delivered to the vicinity of the lead through a long, flexible 12Fr. (O.D.) PTFE sheath placed coaxially within a 16Fr. (O.D.) PTFE Check-Flo® Introducer Sheath having a Check-Flo® Valve with stopcock at its proximal end. The device is comprised at the distal end of a nitinol wire needle's eye retrieval mechanism consisting of a "needle's eye" loop and "threader" with stainless steel sleeves housed within a PTFE protective cover sheath. The snare is activated through the forward advancement of the threader by fully depressing the plunger. The item is captured between the threader and needle's eye. The inner sheath is advanced forward closing the snare and securely capturing the lead or other foreign object. The Needle's Eye Snare® Retrieval Set - 54cm has nominal usable length of 54cm.
Test Data:
The following testing was provided to support a determination of substantial equivalence to the predicate device:
- . Particulate Testing - Testing was performed to show that particulates from the device are comparable to the predicate and meet the requirements of USP 778. The predetermined acceptance criteria were met.