(88 days)
Retriever -18 Endovascular Snare (K914067)
Not Found
No
The device description and performance studies focus on mechanical properties and functionality for foreign object retrieval, with no mention of AI or ML.
No
The device is designed for the retrieval of foreign objects, not for the treatment or diagnosis of a disease or condition in itself. It is an instrument used to correct an issue rather than provide therapy.
No
This device is designed for the retrieval of foreign objects from the body, which is a therapeutic or interventional procedure, not a diagnostic one. It does not provide information about a patient's condition or diagnose a disease.
No
The device description clearly outlines physical components such as a braided catheter shaft, radiopaque basket, corewire, luer fitting, and hydrophilic coating, 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 states that the device is designed for the retrieval of intravascular foreign objects during interventional radiologic procedures. This is a physical intervention within the body.
- Device Description: The description details a physical device (catheter, basket, corewire) used for mechanical retrieval.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for a therapeutic or interventional purpose.
N/A
Intended Use / Indications for Use
The In-Time™ Retrieval Device is designed for use with a guiding catheter for the retrieval of intravascular foreign objects such as coils, balloons, portions of catheters and / or loop wires misplaced during interventional radiologic procedures in peripheral, neuro and cardiovasculature.
Product codes (comma separated list FDA assigned to the subject device)
MMX
Device Description
The In-Time™ Retrieval Device consists of a braided catheter shaft, with a radiopaque basket attached to the distal tip of the catheter. The inner lumen of the catheter contains a flexible, guiding corewire, which is tapered from the proximal to distal end. The corewire extends distally 3 cm from the basket and is not removable from the catheter. The corewire can be rotated freely as well as moved distally and proximally within the catheter approximately 1.5 cm. The 3 cm radiopaque distal coil extending from the basket facilitates fluoroscopic visualization. A luer fitting is located on the catheter hub and is used for the attachment of accessories and to facilitate the continuous flush of solution. The catheter shaft is coated with HYDROLENE™, a hydrophilic coating that reduces friction during manipulation in a guide catheter and in blood vessels. The In-Time™ Retrieval Device is designed to be used with a guide catheter. The In-Time™ Retrieval Device can be used in vessel diameters ranging from 2 mm to 4 mm. Each In-Time™ Retrieval Device is packaged with the following accessory items: catheter introducer, shaping mandrel, torquer and Rotating Hemostatic Valve (RHV). The items are sealed in a sterile pouch located within the larger pouch. All component materials of the In-Time™ Retreival Device are biocompatible in accordance with ISO 10993-1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, neuro and cardiovasculature
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)
Verification Test Summary Table: Predicate Retriever™-18 Endovascular Snare vs In-Time™ Retrieval Device
| Test or Point of Comparison | In-Time™ Retrieval Device |
|---|---|
| Biocompatibility | Meets acceptance criteria established by ISO 10993-1. |
| Dimensional Tests | Meets acceptance criteria established for device. |
| Friction | Meets acceptance criteria established for predicate device. |
| Foreign Body Removal | Meets acceptance criteria established for predicate device. |
| Sterilization | Meets acceptance criteria established for predicate device. |
Verification Test Summary Table: In-Time™ Retrieval Device
| Functional Test | In-Time™ Retrieval Device |
|---|---|
| Tensile | Meets acceptance criteria established for device. |
| Rotation | Meets acceptance criteria established for device. |
| Tip Buckling | Meets acceptance criteria established for device. |
| Turns to Failure | Meets acceptance criteria established for device. |
| Basket Activation Force | Meets acceptance criteria established for device. |
| Basket Closing Force | Meets acceptance criteria established for device. |
| Surface Roughness | Meets acceptance criteria established for device. |
| Particulate Test | Meets acceptance criteria established for device. |
| Withdrawal Force from Catheter | Meets acceptance criteria established for device. |
Key Results: The In-Time™ Retreival Device is substantially equivalent to the predicate Retriever™-18 Endovascular Snare with regards to safety and performance characteristics.
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.
Retriever -18 Endovascular Snare (K914067)
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
K014/09 (P. 1 of 3)
IX. 510(k) Summary of Safety and Effectiveness
MAR 1 2 2002
| SUBMITTER: | Boston Scientific Target
47900 Bayside Parkway
Fremont, CA 94538 |
| ------------ | ------------------------------------------------------------------------ |
|---|
CONTACT PERSON: Seth A. Schulman TEL: 510-440-7753 FAX: 510-440-7752 E-MAIL: schulmas@bsci.com
DATE PREPARED: December 7, 2001
CLASSIFICATION NAME: Retrieval Device (21 CFR Section 870.1250)
COMMON NAME: Retrieval Device
PROPRIETARY NAME: In-Time™ Retrieval Device
Retriever -18 Endovascular Snare (K914067) PREDICATE DEVICE:
The In-Time™ Retrieval Device consists of a braided catheter DEVICE DESCRIPTION: shaft, with a radiopaque basket attached to the distal tip of the catheter. The inner lumen of the catheter contains a flexible, guiding corewire, which is tapered from the proximal to distal end.
The corewire extends distally 3 cm from the basket and is not removable from the catheter. The corewire can be rotated freely as well as moved distally and proximally within the catheter approximately 1.5 cm. The 3 cm radiopaque distal coil extending from the basket facilitates fluoroscopic visualization.
A luer fitting is located on the catheter hub and is used for the attachment of accessories and to facilitate the continuous flush of solution.
The catheter shaft is coated with HYDROLENE™, a hydrophilic coating that reduces friction during manipulation in a guide catheter and in blood vessels.
The In-Time™ Retrieval Device is designed to be used with a guide catheter.
The In-Time™ Retrieval Device can be used in vessel diameters ranging from 2 mm to 4 mm.
Image /page/0/Picture/17 description: The image shows the logo for Boston Scientific Target. The words "Boston Scientific" are stacked on top of each other in a serif font. Below that, the word "TARGET" is written in a bold, sans-serif font with a line above it.
510(k) Premarket Notification In-Time™ Retrieval Device
1
K014109 (P.2 of 3)
Each In-Time™ Retrieval Device is packaged with the following accessory items: catheter introducer, shaping mandrel, torquer and Rotating Hemostatic Valve (RHV). The items are sealed in a sterile pouch located within the larger pouch.
The In-Time™ Retrieval Device is designed for use with a INTENDED USE: guiding catheter for the retrieval of intravascular foreign objects such as coils, balloons, portions of catheters and / or loop wires misplaced during interventional radiologic procedures in peripheral, neuro and cardiovasculature.
All component materials of the In-Time™ Retreival Device are MATERIALS: biocompatible in accordance with ISO 10993-1.
TECHNOLOGICAL CHARACTERISTICS COMPARISON:
| Test or Point of Comparison | In-Time™ Retrieval Device |
|---|---|
| Biocompatibility | Meets acceptance criteria established by ISO 10993-1. |
| Dimensional Tests | Meets acceptance criteria established for device. |
| Friction | Meets acceptance criteria established for predicate device. |
| Foreign Body Removal | Meets acceptance criteria established for predicate device. |
| Sterilization | Meets acceptance criteria established for predicate device. |
Verification Test Summary Table: Predicate Retriever™-18 Endovascular Snare vs In-Time™ Retrieval Device
Image /page/1/Picture/8 description: The image shows the logo for Boston Scientific Target. The words "Boston Scientific" are stacked on top of each other in a serif font. Below that is the word "TARGET" in a sans-serif font. A line separates the two sections of text.
2
K014109 (P.3 of 3)
Verification Test Summary Table: In-Time™ Retrieval Device
| Functional Test | In-Time™ Retrieval Device |
|---|---|
| Tensile | Meets acceptance criteria established for device. |
| Rotation | Meets acceptance criteria established for device. |
| Tip Buckling | Meets acceptance criteria established for device. |
| Turns to Failure | Meets acceptance criteria established for device. |
| Basket Activation Force | Meets acceptance criteria established for device. |
| Basket Closing Force | Meets acceptance criteria established for device. |
| Surface Roughness | Meets acceptance criteria established for device. |
| Particulate Test | Meets acceptance criteria established for device. |
| Withdrawal Force from Catheter | Meets acceptance criteria established for device. |
Conclusion:
The In-Time™ Retreival Device is substantially equivalent to the predicate Retriever™-18 Endovascular Snare with regards to safety and performance characteristics.
Boston
Scientific
TARGET
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles embedded within its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 2 2002
Mr. Seth A. Schulman Senior Regulatory Affairs Specialist Boston Scientific/Target 47900 Bayside Parkway Fremont, California 94538
Re: K014109
Trade/Device Name: In-Time™ Retrieval Device Regulation Number: 870.5150 Regulation Name: Percutaneous retrieval device Regulatory Class: II Product Code: MMX Dated: December 7, 2001 Received: December 14, 2001
Dear Mr. Schulman:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
4
Page 2 - Mr. Seth A. Schulman
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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,
fo Mark A. Wilkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
KO14109 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Name: In-Time™ Retrieval Device
Indications For Use:
The In-Time™ Retrieval Device is designed for use with a guiding catheter for the retrieval of intravascular foreign objects such as coils, balloons, portions of catheters and / or loop wires misplaced during interventional radiologic procedures in peripheral, neuro and cardiovasculature.
| In-Time™ 4 and 6 strand / Guiding Catheter Selection Guide | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | ------------------------------------------------------------ |
| In-Time™
Model | In-Time™
Outer Diameter | Minimum Guiding
Catheter Internal
Diameter |
|-------------------|----------------------------|--------------------------------------------------|
| 4 strand | 3.0 F | 6 F |
| 6 strand | 3.0 F | 6 F |
(Please do not write below this line - continue on another page if needed)
| Concurrence of CDRH, Office of Evaluation (ODE) | |
|---|---|
| ------------------------------------------------- | -- |
| Prescription Use: | X |
|---|---|
| (Per 21 CFR §801.109) |
| OR Over-The-Counter Use: | |
|---|---|
| -- | ---------------------------------------------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| -- | --------------------------------------------------------------------------------------------------------------------- |
Division of General. Restorative
and Neurological Devices
| 510(k) Number | K014109 |
|---|---|
| --------------- | ---------------------------------------------------------- |
Page 47 of 47
510(k) Premarket Notification ~ In-Time™ Retrieval Device