(133 days)
intended for single use by trained physician to assist in vessel cannulation.
Vascular Access Kit - containing dilators, guide wire, scalpel, introducer needle, and syringe.
The provided text describes the 510(k) submission for the Avalon Elite Vascular Access Kit. This is a medical device, and the information presented primarily focuses on its substantial equivalence to a predicate device based on validation testing. It does not describe an AI/ML-based device, a comparative effectiveness study with human readers, or an algorithm-only standalone performance study. Therefore, several sections of your request are not applicable.
Here's an analysis of the provided text based on your request, focusing on what is available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list "acceptance criteria" in a quantitative manner (e.g., "device must achieve X% accuracy"). Instead, it lists validation tests conducted to demonstrate safety and effectiveness compared to a predicate device. The "reported device performance" is a general conclusion that the device "is as safe and effective as the legally marketed predicate device" based on these tests.
| Validation Test | Reported Device Performance |
|---|---|
| Biocompatibility | Concluded to be safe and effective (implicitly met predicate's standards) |
| Packaging Integrity | Concluded to be safe and effective (implicitly met predicate's standards) |
| Transportation Integrity | Concluded to be safe and effective (implicitly met predicate's standards) |
| Sterilization Validation | Concluded to be safe and effective (implicitly met predicate's standards) |
| Functional Testing | Concluded to be safe and effective (implicitly met predicate's standards) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for any of the validation tests. It also does not provide information on data provenance (country of origin, retrospective/prospective). This type of detail is typically found in the full study reports, not the 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualitications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the device is not an AI/ML-based diagnostic device that relies on expert interpretation for ground truth establishment. The validation tests are largely laboratory-based and engineering assessments.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There's no mention of an adjudication process, as the validation tests are not based on subjective interpretation requiring expert consensus.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is a physical vascular access kit, not an AI-assisted diagnostic tool, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical medical kit and does not involve an algorithm with standalone performance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the validation tests conducted (Biocompatibility, Packaging Integrity, Transportation Integrity, Sterilization Validation, Functional Testing), the "ground truth" would be established through defined scientific and engineering standards and methods relevant to each test. For example:
- Biocompatibility: In vitro and/or in vivo tests according to ISO standards (e.g., ISO 10993 series). Ground truth is meeting predefined toxicity/irritation thresholds.
- Packaging/Transportation Integrity: Physical tests to ensure sterility barrier and product integrity are maintained under simulated conditions. Ground truth is successful completion of tests without integrity compromise.
- Sterilization Validation: Microbiological testing and adherence to validated sterilization cycles (e.g., ISO 11135 or 11137). Ground truth is achieving a specified sterility assurance level (SAL).
- Functional Testing: Bench testing to evaluate component strength, fit, ease of use, etc. Ground truth is meeting specified performance parameters.
8. The sample size for the training set
Not applicable. The device is not an AI/ML-based device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML model, the establishment of ground truth for such a set is irrelevant.
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NOV 1 8 2008
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510(k) Summary As required by Section 807.92 (c)
| Owner's Name: | Avalon Laboratories, LLC |
|---|---|
| Address: | 2610 E. Homestead PlaceRancho Dominguez, CA 90220USA |
| 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
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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
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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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§ 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).