(86 days)
Boston Scientific "In-Time" retriever, Microvena microsnare
Not Found
No
The device description and performance studies focus on mechanical properties and biocompatibility, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML algorithms.
Yes
Explanation: The device is used to retrieve foreign objects from the body's vasculature, which is a therapeutic intervention aimed at treating a medical condition.
No
The device is used for the retrieval of foreign objects, which is a therapeutic intervention, not a diagnostic one. It helps in removing something, not in identifying a medical condition.
No
The device description clearly states it is a physical device with grasping jaws attached to a flexible wire, made of radio opaque material, and intended for single use. It is a hardware device used in conjunction with other hardware (microcatheter).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- ARD Function: The Alligator Retrieval Device (ARD) is designed to be used inside the body (in vivo) to physically retrieve foreign objects from blood vessels. It is a surgical/interventional tool, not a diagnostic test performed on a sample.
The description clearly indicates its use in a clinical procedure within the patient's vasculature, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The device is intended for use in the peripheral and neuro-vasculature for foreign body removal.
The Alligator™ Retrieval Device (ARD) is indicated for the use in retrieval of foreign objects in peripheral and neuro vasculature.
Product codes
DQY
Device Description
The Alligator Retrieval Device (ARD) is a retriever with grasping jaws attached to the tip of a flexible wire. The device is designed to be used in conjunction with off-the-shelf 0.21 in. (0.51mm) ID (inner diameter) microcatheter. The grasping jaws and the distal end of the ARD device are made of radio opaque material facilitating fluoroscope visualization. The ARD is for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscope visualization
Anatomical Site
peripheral and neuro-vasculature
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)
The ARD meets ISO 10993 for short-term (less than 24-hours) implantables, meets performance requirements of weld strength and force-to-open, and is provided sterile.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Boston Scientific "In-Time" retriever, Microvena microsnare
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c)
Submitted by: Chestnut Medical Technologies, Inc. 173 Jefferson Drive Menlo Park, CA 94025 Tel 650.566.0057 Fax 650.566.0072
MAR 2 4 2005
Contact Person: Anna Longwell Anna Longwell PC 3583 Ross Road Palo Alto, CA 94303 Tel 650.213.9162 Fax 650.213.9164 anna.longwell@fdclaw.com
Date summary prepared: 29 October 2004
Trade Name: Alligator™ Retrieval Device (ARD)
Common Name: Endovascular snare device
Classification Name: unknown
Device Description:
The Alligator Retrieval Device (ARD) is a retriever with grasping jaws attached to the tip of a flexible wire. The device is designed to be used in conjunction with off-the-shelf 0.21 in. (0.51mm) ID (inner diameter) microcatheter. The grasping jaws and the distal end of the ARD device are made of radio opaque material facilitating fluoroscope visualization. The ARD is for single use only.
Indications for Use: The device is intended for use in the peripheral and neuro-vasculature for foreign body removal.
Predicate Devices: Boston Scientific "In-Time" retriever Microvena microsnare
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Comparision to Predicate Devices to Support Substantial Equivalence Determination:
The ARD is made of similar materials and has similar construction to the predicate devices listed above. Also, the ARD has substantially the same intended use as the predicate devices. Although the differences in construction and materials are incidental, the ARD was tested for biocompatibility. The ARD meets ISO 10993 for short-term (less than 24-hours) implantables, meets performance requirements of weld strength and force-to-open, and is provided sterile.
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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 4 2005
Chestnut Medical Technologies, Inc. c/o Ms. Patricia L. Murphy KEMA Quality B.V. 4377 County Line Road Chalfont, Pennsylvania 18914
Re: K043580
K043380
Trade/Device Name: Alligator™ Retrieval Device (ARD) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: DQY Dated: March 8, 2005 Received: March 9, 2005
Dear Ms. Murphy:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section >10(x) premainer nethstantially equivalent (for the indications referenced above and nave uctchined the acrescented cate devices marketed in interstate for use stated in the encrosule) to regary mances promotical Device Ameridatest Hood Drun commerce prior to May 28, 1970, the chance with the provisions of the Federal Food, Drug. devices that have been reciassified in accordance while as proval approval application (PMA).).
and Cosmetic Act (Act) that do not require approval of a premarket approvalize and Cosment Act (Act) that do not require apple var seneral controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls provi You may, therefore, market the device, beefer courements for annual registration. Iisting of general controls provisions of the free mendate comments of the magainst 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 classifica (see above) the existing major regulations allecting your device can may be subject to such adultional controlls. Entrological on 898. In addition, FDA may be found in the Code of Pouchar Sneerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuates or wordevice complies with other requirements of the Act
that FDA has made a determination that your device complies with other require that FDA has made a delommance in administered by other Federal agencies. You must of any Federal statutes and regulations administered by comply with all the Act's requirements, including, but not limited to: registration and listing (21 comply with an the Act stequirements, and manufacturing practice requirements as set CFR Part 807), labeling (21 CFRT art 807), government (20); and if applicable. the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); 1950 form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Patricia L. Murphy
This letter will allow you to begin marketing your device as described in your Section 5 (0(k) I his letter will anow you to begin manceing your intial equivalence of your device your device premarket nothcation. The PDA miding of backerial of 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 80 ), please If you desire specific advice for your done of (240) 276-0115. Also, please note the regulation entitled, contact the Office of Complance at (210) = if & = = = = = 807.97). You may obtain "Misbranding by reference to premance notifications in the Act from the Division of Small other geleral information on your responser Assistance at its toll-free number (800) 638-2041 or btw.) Manufacturers, International and Outsahher villeww.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Elithm br
Miriam C. Provost, Ph Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Ko43SPO
Indications for Use
| 510(k) Number (if known): | Pending |
|---|---|
| Device Name: | Alligator™ Retrieval Device (ARD) |
| Indications For Use: | The Alligator Retrieval Device (ARD) is indicated for the use in retrieval of foreign objects in peripheral and neuro vasculature. |
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)
. . . .
Signature
043580
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