(183 days)
Not Found
No
The device description and performance studies focus on mechanical properties and physical dimensions, with no mention of AI or ML.
No.
The device is an adapter intended to facilitate the use of other devices (dilators and guidewires) during diagnostic and therapeutic procedures, but it does not perform a therapeutic function itself. Its purpose is to provide access and maintain hemostasis, acting as an accessory.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "a variety of diagnostic and therapeutic procedures," indicating its involvement in diagnostic processes.
No
The device description clearly indicates it is a physical, sterile, single-use device made of polyethylene, designed to be inserted into veins and/or arteries.
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 to facilitate the introduction of other devices into veins and arteries during diagnostic and therapeutic procedures. This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description details a physical adapter designed to bridge the size difference between guidewires and dilators, again for use within the body.
- Anatomical Site: The specified anatomical site is "veins and/or arteries," which are internal structures of the body.
- Performance Studies: The performance studies mentioned (tensile testing, dimensional specifications, insertion forces, useability on a simulated clinical bench model) are consistent with evaluating the physical and functional performance of a medical device used in a procedural setting, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to be used in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Adapter is intended to allow the use of a .018" guidewire with a .035" or .038" guidewire compatible dilator up to 23cm in overall length.
The Adapter is intended to allow the use of a .018" guidewire with a 0.035" or .038" guidewire compatible dilator up to 23 cm in overall length and to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
Product codes (comma separated list FDA assigned to the subject device)
DRE
Device Description
The Adapter is a sterile, single use device that is hollow and has a tapered increase in outer diameter on one end. This shape allows the Adapter to fill the excess space between .018" guidewires and dilators with larger inner diameters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
veins and/or arteries
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 Dilator Adapter was subjected to tensile testing to demonstrate that it met ISO11070-1998 specifications for dilators. The Adapter also underwent testing for dimensional specifications, design verification and validation including insertion forces and useability as assessed on a simulated clinical bench model.
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
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).
0
Arstasis
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| SECTION 4: 510(K) SUMMARY | MAY 24 2011 | |
|---|---|---|
| Sponsor/Submitter: | Arstasis, Inc. | |
| 1021 Howard Avenue, Suite C | ||
| San Carlos, CA 94070 | ||
| Contact Person: | Debra Cogan | |
| Director, Regulatory & Clinical Affairs | ||
| Phone: (650) 508-1549 x273 | ||
| Fax: (650) 594-4326 | ||
| Date of Submission: | November 19, 2010 | |
| Device Trade Name: | Arstasis Dilator Adapter | |
| Common Name: | Dilator Adapter | |
| Device Classification: | Class II | |
| Regulation Number: | 21 CFR 870.1310 | |
| Classification Name: | dilator, vessel, for percutaneous catheterization | |
| Product Code: | DRE | |
| Predicate Device: | Prelude Sheath Introducer (K070159) | |
| Device Description: | The Adapter is a sterile, single use device that is hollow and has a | |
| tapered increase in outer diameter on one end. This shape allows the | ||
| Adapter to fill the excess space between .018" guidewires and | ||
| dilators with larger inner diameters. | ||
| Indications for Use: | The Adapter is intended to allow the use of a .018" guidewire with a | |
| .035" or .038" guidewire compatible dilator up to 23cm in overall | ||
| length. | ||
| Technological | ||
| Characteristics | The Dilator Adapter is a polyethylene bump extrusion that fits into a | |
| .035"-.038" compatible vessel dilator with an internal diameter-sized-- | ||
| to an .018" guidewire. | ||
| Performance Data | The Dilator Adapter was subjected to tensile testing to demonstrate | |
| that it met ISO11070-1998 specifications for dilators. The Adapter | ||
| also underwent testing for dimensional specifications, design | ||
| verification and validation including insertion forces and useability as | ||
| assessed on a simulated clinical bench model. | ||
| Summary of | ||
| Substantial | ||
| Equivalence: | The Arstasis Dilator Adapter is substantially equivalent to the | |
| predicate device as confirmed through performance testing. |
1
!.
SECTION 3: INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | K103421 |
|---|---|
| Trade Name: | Arstasis Dilator Adapter |
| Common Name: | dilator, vessel, for percutaneous catheterization |
| Indications For Use: | The Adapter is intended to allow the use of a .018" guidewire with a |
| .035" or .038" guidewire compatible dilator up to 23cm in overall length. |
Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page of of __ of _
(Posted November 13, 2003)
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(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number_ 165992
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three heads, representing health, human services, and the department's commitment to serving the nation. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The seal is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 2882011
Arstasis Inc. c/o Ms. Debra Cogan Director, Regulatory & Clinical Affairs 740 Bay Road Redwood City, CA 94063
Re: K103421
Trade Name: Arstasis Dilator Adapter Regulation Number: 21 CFR 870.1310 Regulation Name: Dilator, Vessel, for Percutaneous Catheterization Regulatory Class: II (two) Product Code: DRE Dated: May 12, 2011 Received: May 13, 2011
Dear Ms. Cogan:
This letter corrects our substantially equivalent letter of May 24, 2011.
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.
3
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 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure Indications for Use Statement
4
Arstasis Dilator Adaptor K103421/A001 Attachment A
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Trade Name: Arstasis Dilator Adapter
dilator, vessel, for percutaneous catheterization Common Name:
- "The Adapter is intended to allow the use of a .018" guidewire with a Indications For Use: 0.035" or .038" guidewire compatible dilator up to 23 cm in overall length and to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures."
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Page ___ of ___ | |
| (Posted November 13, 2003) |
Division Sign-Off
Division of Cardiovascular Devices
| 510(k) Number | K103421 |
|---|---|
| --------------- | --------- |