(67 days)
The Introducer Assembly with Rotator Lock is intended to provide access to the venous system for device entry, when used in conjunction with additional percutaneous entry devices.
The Introducer Assembly with Rotator Lock consists of a dilator and a split sheath introducer that is used to provide access to the venous system for device entry, when used in conjunction with additional percutaneous critry devices.
Here's the analysis of the provided text regarding the acceptance criteria and study for the "Introducer Assembly with Rotator Lock":
Based on the provided document, the device described is a physical medical device (an introducer assembly) and not an AI/Software as a Medical Device (SaMD). Therefore, the typical acceptance criteria and study methodologies applicable to AI/SaMD (such as performance metrics like sensitivity, specificity, AUC, human reader studies, ground truth establishment with experts, etc.) are not present or relevant in this submission.
The document is a 510(k) Summary of Safety and Effectiveness for a a Class II medical device, which focuses on demonstrating substantial equivalence to a predicate device and adherence to biological safety and verification/validation testing for physical design and materials.
Here's a breakdown of the requested information based on the provided text, acknowledging the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biological Safety: Adherence to ISO 10993 Part 1 "Biological Evaluation of Medical Devices" | All materials used in fabrication passed biological safety tests as outlined in ISO 10993 Part 1. |
| Functional Verification & Validation: Acceptability for intended use (providing access to the venous system for device entry) | Verification and Validation testing was performed, and the device's design and materials were found to be acceptable for the intended use. |
| Substantial Equivalence: To a legally marketed predicate device (TFX Medical Introducer Assembly (K931911)) | Determined to be substantially equivalent to the TFX Medical Introducer Assembly (K931911) with respect to functionality, design, placement, and use. FDA concurred with this determination. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable or provided in the context of this 510(k) submission for a physical introducer assembly. The testing mentioned (biological safety, verification, and validation) would typically involve laboratory and engineering bench testing of device samples, rather than human data or clinical studies with a "test set" in the AI/SaMD sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable or provided. Ground truth in the context of AI/SaMD (e.g., diagnostic accuracy) is not relevant for this physical device. Verification and validation testing for a physical device would be executed by engineers, quality control personnel, and potentially in simulated environments or animal models for certain aspects, but not for establishing "ground truth" to train or test an algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or provided. Adjudication methods are typically used in clinical studies or expert review processes, which are not detailed or implied for the device testing described.
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
No, a multi-reader, multi-case comparative effectiveness study was not done. This type of study is specifically relevant for AI-assisted diagnostic devices, which the "Introducer Assembly with Rotator Lock" is not.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not describe the use of "ground truth" in the way it's understood for AI/SaMD. The "truth" for this device's performance would be derived from successful completion of engineering tests, material biocompatibility assessments, and functional verification against design specifications and intended use. For example:
- Biocompatibility: In vitro and in vivo tests confirming non-toxicity and compatibility with biological systems.
- Mechanical Performance: Bench testing to ensure physical properties (e.g., strength, flexibility, lubricity) meet specifications.
- Functional Performance: Confirmation that the device can successfully facilitate the introduction of other devices into the venous system without failure or undue difficulty.
8. The sample size for the training set
This information is not applicable or provided. The device is not an AI/SaMD and therefore does not have a "training set" in that context.
9. How the ground truth for the training set was established
This information is not applicable or provided for the same reasons as #8.
Summary of the Study and Conclusion from the Document:
The study performed focused on biological safety testing (in accordance with ISO 10993 Part 1) and verification and validation testing of the device's design and materials. The results indicated that the materials passed biological safety standards and that the design and materials were acceptable for the intended use. The primary basis for market clearance was the demonstration of substantial equivalence to a predicate device (TFX Medical Introducer Assembly (K931911)) in terms of functionality, design, placement, and use. The FDA reviewed these submissions and determined that the device was substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.
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Image /page/0/Picture/0 description: The image shows the logo for Teleflex Medical. The logo is in black and white. The word "Teleflex" is in a bold, sans-serif font, and the word "MEDICAL" is in a smaller, sans-serif font below the word "Teleflex."
Teleflex Medical Group Headquarters 2345 Waukegan Road Bannockburn, IL 60015 USA 847-572-8002 Phone: 847-572-8001 Fax: www.teleflex.com
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Introducer Assembly with Rotator Lock
A. Name, Address, Phone and Fax Number of Applicant
Kobosil
Teleflex Medical Group Headquarters 2345 Waukegan Road, Suite 140 Bannockburn, IL 60015 USA Phone: 847-572-8002 847-572-8001 Fax:
-5 2006 MAY
B. Contact Person
Lori Hays Senior Manager, Regulatory Affairs
C. Date Prepared
February 24, 2006
D. Device Name
Trade Name: Introducer Assembly with Rotator Lock
Common Name: Catheter Introducer
Classification Name: Catheter Introducer
Product Code: DYB
Regulation Number: 870.1340
Class: II
E. Device Description
The Introducer Assembly with Rotator Lock consists of a dilator and a split sheath introducer that is used to provide access to the venous system for device entry, when used in conjunction with additional percutaneous critry devices.
Production of Children Children Children Children
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F. Intended Use
The Introducer Assembly with Rotator Lock is intended to provide access to the venous system The Introduct I LSSeniory with conjunction with additional percutaneous entry devices.
G. Substantial Equivalence
The Introducer Assembly with Rotator Lock is substantially equivalent to the TFX Medical I he introducer Assembly (1993191) with respect to functionality, design, placement and use.
H. Summary of Testing
All materials used in the fabrication of the Introducer Assembly with Rotator Lock were An matchals used in the faction safety tests as outlined in ISO 10993 Part 1 "Biological Evaluation of Medical Devices". Verification and Validation testing was performed Bloogical Evaluation of rivelion design and materials were found to be acceptable for the intended use
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 5 2006
Teleflex Medical Group Headquarters c/o Ms. Lori Hays Senior Manager, Regulatory Affairs 2345 Waukegan Road, Suite 140 Bannockburn, IL 60015
Re: K060519
Introducer Assembly with Rotator Lock Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer -Regulatory Class: II Product Code: DYB Dated: April 6, 2006 Received: April 10, 2006
Dear Ms. Hays:
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 indivations for use stated in the enclosure) to legally marketed predicate devices marked 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, isting 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, TDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast be devised and I Driv issualited your device complies with other requirements of the Act than Federal statutes and regulations administered by other Federal agencies. You must or any I odelui barees and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of N i at 807), its ensigned (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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Duna R. Wochner
\ 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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Image /page/4/Picture/1 description: The image shows the logo for Teleflex Medical. The word "Teleflex" is in a bold, sans-serif font, with the "T" stylized to look like a right angle. Below the word "Teleflex" is the word "MEDICAL" in a smaller, sans-serif font. The logo is black and white.
Teleflex Medical Group Headquarter 2345 Waukegan Koad Bannockburn, IL, 60015 USA 847-572-8002 Phone: Fax: 847-572-8001 www.teleflex.com
Indications for Use
Ko60519
510(k) Number (if known): K060519
Device Name: Introducer Assembly with Rotator Lock
Indications For Use:
The Introducer Assembly with Rotator Lock is intended to provide access to the venous system for device entry, when used in conjunction with additional percutaneous entry devices.
Prescription Use (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Lunes
(Division Sign-Off)
Cardiovascular Devices
(A) Number_1 (06
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§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).