(133 days)
Not Found
No
The device description lists standard components of a vascular access kit and there are no mentions of AI, ML, or image processing. The performance studies focus on standard device validations like biocompatibility and sterilization, not algorithmic performance.
No
The device is intended to assist in vessel cannulation for diagnostic or interventional procedures, not to treat a disease or condition itself.
No
The device, a 'Vascular Access Kit', is intended to 'assist in vessel cannulation' and contains items like dilators, guide wire, and scalpel, which are tools for a medical procedure rather than for diagnosing a condition. The performance studies focus on safety and effectiveness for its intended procedural use, not on diagnostic accuracy.
No
The device description explicitly lists hardware components (dilators, guide wire, scalpel, introducer needle, and syringe) and the performance studies focus on hardware-related validations (Biocompatibility, Packaging Integrity, Transportation Integrity, Sterilization Validation, Functional Testing).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to assist in vessel cannulation." This is a procedure performed directly on the patient's body to access a blood vessel.
- Device Description: The components listed (dilators, guide wire, scalpel, introducer needle, syringe) are all instruments used for a surgical or interventional procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status, diagnosis, or treatment.
IVDs are typically used in laboratories or point-of-care settings to analyze biological samples. This device is clearly intended for use in vivo (within the body) during a medical procedure.
N/A
Intended Use / Indications for Use
intended for single use by trained physician to assist in vessel cannulation.
Product codes
DRE
Device Description
Vascular Access Kit - containing dilators, guide wire, scalpel, introducer needle, and syringe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessel
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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
Validation Testing was used to establish the performance characteristics of the Vascular Access Kit as follows:
Biocompatibility
Packaging Integrity
Transportation Integrity
Sterilization Validation
Functional Testing
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
NOV 1 8 2008
ﻳﺔ ﺍﻟﻤﺘﺤﺪﺓ
510(k) Summary As required by Section 807.92 (c)
| Owner's Name: | Avalon Laboratories, LLC |
|---|---|
| Address: | 2610 E. Homestead Place |
| Rancho Dominguez, CA 90220 | |
| USA | |
| Phone: | 310 761-8660 |
| Fax: | 310 761-8665 |
| Contact Person: | Lee Wirth/Director of Quality Assurance and Regulatory Affairs |
| Summary Prepared: | July 3, 2008 |
| Name of device: | Vascular Access Kit |
| Trade/Proprietary Name: | Avalon Elite Vascular Access Kit |
| Classification Name: | 21 CFR 870.1310 - Dilator |
| Product Code: | DRE |
| Substantially Equivalent: | K070749 Estech Percutaneous Insertion Dilator Kit |
| Description: | Vascular Access Kit - containing dilators, guide wire, scalpel, introducer needle, and syringe. |
| Intended Use: | Intended for single use by trained physician to assist in vessel cannulation. |
| Comparison to Predicate: | Similar in terms of design (physical characteristics), materials, content, intended use, performance characteristics, packaging, and sterilization. |
| Supporting Data: | Validation Testing was used to establish the performance characteristics of the Vascular Access Kit as follows: |
| ● Biocompatibility | |
| ● Packaging Integrity | |
| ● Transportation Integrity | |
| ● Sterilization Validation | |
| ● Functional Testing | |
| Conclusions: | The results of these validation tests demonstrate the kit is as safe and effective as the legally marketed predicate device. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 2008
Avalon Laboratories, LLC c/o Mr. Lee Wirth Director, QA/RA 2610 E. Homestead Place Rancho Dominquez, CA 90220
Re: K081940
Trade/Device Name: Avalon Elite Vascular Access Kit Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel dilator for percutaneous catheterization Regulatory Class: Class II Product Code: DRE Dated: September 23, 2008 Received: September 26, 2008
Dear Mr. Wirth:
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 agencics. 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
2
Page 2 - Mr. Lee Wirth
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. 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
K 081940 510(k) Number (if known):
Device Name: Avalon Elite Vascular Access Kit
Indications For Use: intended for single use by trained physician to assist in vessel cannulation.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
antar Device s Division of Cardiove 240 510kj N
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