(185 days)
No
The device description and performance studies focus on mechanical properties and functionality, with no mention of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is intended to remove foreign objects from the body, which is not considered a therapeutic function based on the provided information.
No
The device is described as a "Vascular Retriever" intended to "snare a foreign body and withdraw it," indicating a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components such as a nitinol wire snare, inner catheter, metal cannula, and outer Flexor sheath, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "snare a foreign body and withdraw it to a peripheral vascular location." This describes a procedure performed within the body (in vivo) to retrieve an object.
- Device Description: The device is a physical tool (snare, catheter, sheath) designed for mechanical manipulation within the vascular system.
- Lack of IVD Characteristics: IVD devices are used to examine specimens outside the body (in vitro), such as blood, urine, or tissue, to provide information about a patient's health status. This device does not perform any such analysis.
Therefore, the Indy OTW™ Vascular Retriever is a medical device used for an interventional procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Indy OTW™ Vascular Retriever is intended to snare a foreign body and withdraw it to a peripheral vascular location.
Product codes (comma separated list FDA assigned to the subject device)
MMX
Device Description
The Indy OTW™ Vascular Retriever consists of a 4-loop nitinol wire snare attached to an inner catheter (which is attached proximally to a metal cannula) and includes an outer Flexor sheath. The device is compatible with a 0.035 inch wire guide for over-the-wire introduction. The Flexor sheath has a radiopaque band incorporated within the sheath material to identify the location of the sheath's distal tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vascular location
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 and performance testing were conducted to ensure that the Indy OTWTM Vascular Retriever will not elicit an adverse biological response in patients and will reliably perform as intended.
Biocompatibility Testing - Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systematic Toxicity, Hemocompatibility, and Pyrogenicity tests were performed. All test results were acceptable and demonstrate that the device is biocompatible.
Tensile Strength Testing - Peak load values of joints between device components were in accordance with the predetermined acceptance criteria demonstrating that the joints have sufficient strength to remain intact during use.
Simulated Use Testing The Indy OTW™ Vascular Retriever was capable of snaring and removing wire guides and catheter fragments or snaring and repositioning wire guides and catheters within an anatomical model in accordance with the instructions for use. The predetermined acceptance criteria were met.
Liquid Leak Pressure Testing –The sheath hub, Touhy-Borst, and catheter hub did not leak water while pressurized. The predetermined acceptance criterion was met.
Structural Integrity Testing –The device maintained structural integrity under the conditions of the study. The predetermined acceptance criteria were met.
Radiopacity Testing - The catheter tip, sheath tip, and wire loops are visible under standard fluoroscopy. The predetermined acceptance criterion was met.
Immersion Corrosion Testing – No evidence of corrosion was observed. The predetermined acceptance criterion was 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.
K142829, K102484, K110009, K110163, K150970
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).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 2, 2016
Cook Incorporated Mr. Chad Schulenburg Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloomington, IN 47404
Re: K160593
Trade/Device Name: Indy OTW Vascular Retriever Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: MMX Dated: July 29, 2016 Received: August 1, 2016
Dear Mr. Schulenburg:
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 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.
1
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.
Sincerely yours,
Brian D. Pullin -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160593
Device Name Indy OTW™ Vascular Retriever
Indications for Use (Describe)
The Indy OTW Vascular Retriever is intended to snare a foreign body and withdraw it to a peripheral vascular location.
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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Image /page/3/Picture/0 description: The image shows the Cook Medical logo. The logo consists of the word "COOK" in white, uppercase letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, uppercase letters on a red background. The red background is a rectangle with a diagonal cut on the bottom right corner.
510(k) SUMMARY As required by 21 CFR §807.92 Date Prepared: July 29, 2016
I. SUBMITTER
| Submission: | Traditional 510(k) Premarket Notification |
|---|---|
| Applicant: | Cook Incorporated |
| Contact: | Chad Schulenburg |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Contact Phone Number: | (812) 335-3575 ext. 104073 |
| Contact Fax Number: | (812) 332-0281 |
II. DEVICE
Trade Name: Common Name: Classification Name: Regulation/Class: Product Code
Indy OTWTM Vascular Retriever Percutaneous Retrieval Device Embolectomy Catheter 21 CFR §870.5150/Class II MMX
III. PREDICATE DEVICE
The device subject of this submission is considered substantially equivalent to the predicate device, the 4-Loop Vascular Retriever Snare (K112185).
IV. DEVICE DESCRIPTION
The Indy OTW™ Vascular Retriever consists of a 4-loop nitinol wire snare attached to an inner catheter (which is attached proximally to a metal cannula) and includes an outer Flexor sheath. The device is compatible with a 0.035 inch wire guide for over-the-wire introduction. The Flexor sheath has a radiopaque band incorporated within the sheath material to identify the location of the sheath's distal tip.
V. INDICATIONS FOR USE
The Indy OTWIM Vascular Retriever is intended to snare a foreign body and withdraw it to a peripheral vascular location.
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Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, with a registered trademark symbol to the right of the word. Below the word "COOK" is the word "MEDICAL" in white. The background is red.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Indy OTWTM Vascular Retriever and the predicate device, the 4-Loop Vascular Retriever Snare (K112185), are substantially equivalent in that these devices have the same intended use and similar technological characteristics.
| PREDICATE DEVICE | SUBJECT DEVICE | |
|---|---|---|
| 4-Loop Vascular Retriever Snare | ||
| (K112185) | Indy OTW Vascular Retriever | |
| (Subject of this Submission) | ||
| Regulation Number | 870.5150 | Identical |
| Product Code | MMX | Identical |
| Classification Name | Embolectomy Catheter | Identical |
| Class | II | Identical |
| Intended Use | Intended for use in the | |
| cardiovascular system to manipulate | ||
| and retrieve foreign objects, | ||
| including, but not limited to, wire | ||
| guides, coils, balloons, catheters, | ||
| and filters. | Intended to snare a foreign body and | |
| withdraw it to a peripheral vascular | ||
| location. | ||
| Model Number | ||
| Prefix | VRS | INDY |
| Snare Sub-Assembly | 5 Nitinol strands / | |
| 2 Tantalum strands | 5 Nitinol strands / | |
| 2 Platinum strands | ||
| Snare Loops | 4 | Identical |
| Inner Catheter | Radiopaque | |
| Tetrafluoroethylene (TFE) | Nylon radiopaque tubing | |
| Catheter | ||
| Length (cm) | 90 | 55, 100 |
| Sheath | Nylon | Flexor sheath: |
| Nylon outer layer, | ||
| Embedded steel coil, | ||
| PTFE inner liner | ||
| Outer Sheath | ||
| Size (Fr) | 10.0 | 8.0 |
| Connector Cap | Nylon | Identical |
Table 1: Comparison Table
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Image /page/5/Picture/1 description: The image shows the Cook Medical logo. The word "COOK" is in white, sans-serif, uppercase letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif, uppercase letters on a darker red background. The logo is simple and modern.
| PREDICATE DEVICE | SUBJECT DEVICE | |
|---|---|---|
| 4-Loop Vascular Retriever Snare | ||
| (K112185) | Indy OTW Vascular Retriever | |
| (Subject of this Submission) | ||
| Side Arm Assembly | Tuohy-Borst adapter material: | |
| Polycarbonate | ||
| Male luer cap with strap material: | Identical | |
| High density polyethylene/polyvinyl | ||
| chloride | ||
| Wire Guide | ||
| Compatibility | ||
| (diameter in inches) | N/A | 0.035 |
| Packaging | PETG tray | |
| PET-PE / Tyvek pouch | Wire guide holder | |
| PET-PE / Tyvek pouch | ||
| Sterilization Method | EtO | Identical |
| SAL | 10-6 | Identical |
| Shelf Life | 3 years | Identical |
The minor differences in dimensions, materials, and technology as compared to the predicate device were appropriately assessed and do not present any new questions of safety and/or effectiveness. The following devices were referenced to provide additional support: Flexor® Introducers (K142829), SeQure™ Snare System (K102484), Roadrunner® Uniglide® Hydrophilic Wire Guide (K110009), Approach® Pro ST Micro Wire Guides (K110163) and the Coda® Low Profile Balloon Catheter (K150970). Based on the comparison of the design, intended use, materials, fundamental technology, and principle of operation, the subject device is considered to be substantially equivalent to the currently marketed predicate device.
VII. PERFORMANCE DATA
Biocompatibility testing and performance testing were conducted to ensure that the Indy OTWTM Vascular Retriever will not elicit an adverse biological response in patients and will reliably perform as intended.
- . Biocompatibility Testing - Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systematic Toxicity, Hemocompatibility, and Pyrogenicity tests were performed. All test results were acceptable and demonstrate that the device is biocompatible.
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- 트 Tensile Strength Testing - Peak load values of joints between device components were in accordance with the predetermined acceptance criteria demonstrating that the joints have sufficient strength to remain intact during use.
- Simulated Use Testing The Indy OTW™ Vascular Retriever was capable of snaring and removing wire guides and catheter fragments or snaring and repositioning wire guides and catheters within an anatomical model in accordance with the instructions for use. The predetermined acceptance criteria were met.
- . Liquid Leak Pressure Testing –The sheath hub, Touhy-Borst, and catheter hub did not leak water while pressurized. The predetermined acceptance criterion was met.
- Structural Integrity Testing –The device maintained structural integrity under the conditions of the study. The predetermined acceptance criteria were met.
- 그 Radiopacity Testing - The catheter tip, sheath tip, and wire loops are visible under standard fluoroscopy. The predetermined acceptance criterion was met.
- Immersion Corrosion Testing – No evidence of corrosion was observed. The predetermined acceptance criterion was met.
VIII. CONCLUSIONS
The results of the testing provide reasonable assurance that the subject device has been designed such that it will function as intended to snare a foreign body and withdraw it to a peripheral vascular location. The subject device does not raise new questions of safety or effectiveness as compared to the predicate device. This supports a determination of substantial equivalence of the subject device to the predicate device.