(45 days)
Not Found
No
The description explicitly states the device is a set of "manual instruments" and there is no mention of AI, ML, image processing, or any computational components.
No
Explanation: The device is intended to facilitate the introduction of other interventional devices and does not directly provide therapy itself.
No
Explanation: The device is described as manual instruments intended to facilitate the introduction of other interventional devices, rather than to diagnose medical conditions or diseases.
No
The device description explicitly states it consists of physical components (Docking Station, Teirstein Edge, AngioAssist Combination Device) and is provided sterile for single use, indicating it is a hardware device.
Based on the provided information, the AngioAssist is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the AngioAssist is a set of manual instruments intended to facilitate the alignment and introduction of interventional devices within the coronary and peripheral vasculature. This describes a device used in vivo (within the living body) for a procedural purpose.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, laboratory testing, or diagnostic purposes.
Therefore, the AngioAssist is a medical device used for interventional procedures, not an IVD.
N/A
Intended Use / Indications for Use
The AngioAssist is a set of manual instruments intended to facilitate alignment and introduction of interventional devices (i.e., guide wires and catheters) within the coronary and peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The AngioAssist consists of the Docking Station , Teirstein Edge and AngioAssist Combination Device. The devices are provided sterile for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral 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 AngioAssist instruments underwent performance and biocompatibility testing to verify that the device functions in a safe and effective manner. The results of the tests provide reasonable assurance that the devices have been designed and tested to assure conformance to the requirements for the indications for use.
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.
K963171, K062192, K072552, K003398
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
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
5. 510(K) SUMMARY AS REQUIRED BY 21 CFR 807.92
ﻨﮧ
JAN 2 8 2010
510(k) Summary
- ﺧ
510(k) Number: _ KU93822
| Date Prepared | August 26, 2009 |
|---|---|
| Submitter Information | |
| Submitter's Name/Address: | Shepherd Scientific, Inc. |
| 1515 Coast Walk | |
| La Jolla, CA 92037 | |
| Establishment Registration: | TBA |
| Contact Person: | Paul Teirstein, M.D. |
| President | |
| (858) 554-9905 telephone | |
| (858) 459-7285 fax | |
| pteirstein@scrippsclinic.com | |
| Device Information | |
| Trade Name: | AngioAssist |
| Common Name: | Catheter Guide Wire Accessory |
| Classification Name: | Wire, Guide, Catheter |
| Product Code: | DQX |
| Regulation: | Class II, 21 CFR 870.1330 |
| Panel: | Cardiovascular |
Performance Standards
No performance standards applicable to this product have been developed under Section 514 of the Act.
| Predicate Device | Manufacturer | 510(k) Status |
|---|---|---|
| Cinch QR Steerable Guidewire | ||
| Extension Accessories | Cordis Corporation | K963171 |
| Ostial Pro Stent Positioning System | Ostial Solutions, LLC | K062192 |
| Torque Device | Merit Medical Systems, Inc. | K072552 |
| WireClip Torquer | Boston Scientific | K003398 |
| KEEP Accessory Organizer | Merit Medical Systems, Inc. | Exempt |
5.1. Device Description
The AngioAssist consists of the Docking Station , Teirstein Edge and AngioAssist Combination Device. The devices are provided sterile for single use.
1
5.2. Intended Use/Indications for Use
The AngioAssist is a set of manual instruments intended to facilitate alignment and introduction of interventional devices (i.e., guide wires and catheters) within the coronary and peripheral vasculature.
-1,
, ,
:
ﻧﺪ.
5.3. Summary of Non-Clinical Testing
The AngioAssist instruments underwent performance and biocompatibility testing to verify that the device functions in a safe and effective manner. The results of the tests provide reasonable assurance that the devices have been designed and tested to assure conformance to the requirements for the indications for use.
5.4. Statement of Equivalence
The AngioAssist instruments are substantially equivalent to the predicate devices listed above based on a comparison of the indications for use and the technological characteristics. The testing performed confirms that the AngioAssist will perform as intended.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, which is a common symbol used in government seals to represent freedom and strength.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
JAN 2 8 2010
Shepherd Scientific, Inc. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313
Re: K093822
Trade/Device Name: AngioAssist Family Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Accessory Regulatory Class: Class II (two) Product Code: DQX Dated: December 31, 2009 Received: January 6, 2010
Dear Mr. Job:
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 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.
3
Page 2 -- Mr. Mark Job
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 device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
suma R. lahner
Image /page/3/Picture/8 description: The image shows a black and white drawing of a cursive letter. The letter appears to be an 'L' or a stylized 'E'. The letter has a loop at the top and a curved line extending to the right. The drawing is simple and lacks any shading or texture.
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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4. INDICATIONS FOR USE STATEMENT
The Indications for Use Statement is provided on the following page. Indications for Use Statement
510(k) Number (if known): _ K093822_
Device Name: AngioAssist
Indications for Use:
The AngioAssist is a set of manual instruments intended to facilitate alignment and introduction of interventional devices (i.e., guide wires and catheters) within the caronary and perinteral vasculature.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
ourner 2. In time
(Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular Devices
510(k) Number_ko93822