The SEDAT MYSHELL LITE is indicated for assisting, manipulating, and maintaining a seal around diagnostic/interventional devices with an outside diameter <9F (<.098") used in interventional angioplasty procedures.

Device Description

The Sedat Myshell Lite consists of a variety of Y-connectors with a double silicone haemostatic valve within a reduce volume, well fitted for handling interventional procedures. The valve opening/closure mechanism could be activated by the thumb like a control button transforming the resilient valve in a variable geometry permitting to enlarge the valve opening of the silicone membrane. The interventionists make better adjustments for the seal introduction point and the size of the vascular instruments able to be introduced or removed to suit the individual pathology and anatomical conditions of the patient.

AI/ML Overview

Here's an analysis of the provided text regarding the Sedat Myshell Lite device's acceptance criteria and the study used to demonstrate it:

Disclaimer: This device is a medical device (Y-connector with a double silicone haemostatic valve) and NOT an AI/algorithm-powered device. Therefore, many of the requested categories related to AI performance, ground truth, expert review, and training sets are not applicable or cannot be extracted from the provided 510(k) summary. I will highlight what information is present and what is missing based on the nature of this particular device approval.

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Equivalence in Indications for Use (to predicate device K040498)	The Sedat Myshell Lite is indicated for assisting, manipulating and maintaining a seal around diagnostic/interventional devices with an outside diameter <9F (<.098'') use in interventional angioplasty procedures. This is stated as substantially equivalent to the predicate.
Equivalence in Design (to predicate device K040498)	The device consists of "a variety of Y-connectors with a double silicone haemostatic valve within a reduce volume" and an "opening/closure mechanism could be activated by the thumb." Stated as substantially equivalent to the predicate.
Equivalence in Material (to predicate device K040498)	Not explicitly detailed, but stated as substantially equivalent to the predicate.
Equivalence in Function (to predicate device K040498)	The device allows for "better adjustments for the seal introduction point and the size of the vascular instruments," "permitting to enlarge the valve opening of the silicone membrane." Stated as substantially equivalent to the predicate.
Bench performance testing met	"Bench performance testing was presented." (No specific criteria or results are detailed in this summary).

Note: The primary "acceptance criteria" for a 510(k) device like this is demonstrating substantial equivalence to a previously cleared predicate device. The performance is assessed against the predicate's known safety and effectiveness through comparisons of intended use, design, materials, and function, often supported by bench testing. Specific quantitative clinical performance metrics (like sensitivity, specificity, accuracy) are typically not required or reported for Class II devices gaining clearance via substantial equivalence if their function is well-understood and similar to existing devices.

Study Details (Applicability to AI/Algorithm-Powered Devices)

Sample size used for the test set and the data provenance:
- N/A (Not an AI Device): There is no "test set" in the context of an algorithm or AI model for this physical medical device. The evaluation relied on a comparison to a predicate device and bench testing.
- Data Provenance: Bench testing would likely be performed in a laboratory setting by the manufacturer (Sedat, France).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A (Not an AI Device): No expert-established ground truth for an algorithm's test set. The "ground truth" for this device's performance would be its functional performance against engineering specifications and its ability to perform its intended mechanical function (maintaining a seal) during bench testing.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A (Not an AI Device): Not applicable as there is no human adjudication of an AI output for this device.
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:
- N/A (Not an AI Device): This is a physical Y-connector; it does not involve human readers or AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A (Not an AI Device): Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Technical Specifications/Bench Test Results (for mechanical device): The "ground truth" for this device would be its ability to mechanically meet its design specifications and functional requirements (e.g., integrity of the seal, valve opening/closure mechanism, material compatibility, pressure resistance, etc.) demonstrated through bench testing. It's not a diagnostic device requiring a clinical ground truth like pathology or expert consensus on patient conditions.
The sample size for the training set:
- N/A (Not an AI Device): There is no training set for a physical medical device.
How the ground truth for the training set was established:
- N/A (Not an AI Device): Not applicable.

Summary for this specific device:

The Sedat Myshell Lite is a physical medical device, not an AI or algorithm-powered one. Its regulatory clearance (510(k)) focuses on demonstrating substantial equivalence to an already legally marketed predicate device (Myshell device cleared under K040498).

The study that "proves the device meets the acceptance criteria" is outlined as "Bench performance testing." This testing would have confirmed that the device functions as intended and safely, similar to its predicate. The summary explicitly states: "Summary of Clinical Tests (Not Applicable)." This means that no human clinical trials were required or performed to demonstrate the device's safety and effectiveness for this 510(k) clearance, as its function is well-established through the predicate device and bench testing.

Therefore, questions pertaining to AI-specific evaluation metrics, training/test sets, expert adjudication, or MRMC studies are not relevant to this submission.

Summary

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Special 510(k) Premarket Notification Myshell Lite

VII. 510(k) Summary

APR 2 3 2008

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 8807.92, the following summary of information is provided:

A. Submitted by

Catherine Charles Director of Regulatory Affairs and Quality Assurance Sedat 135, Route Neuve 69540 Irigny - France Telephone: +33 472 397 414 Fax: +33 478 518 967

B. Device Name

Trade or Proprietary Name: Sedat Myshell Lite Common or Usual Name: Myshell Lite Y Connector Classification Name: Cardiopulmonary Bypass Adaptor, Stopcock, Mannifold, or Fitting Device Class: Class II Classification: 870.4290 Product Code: DTL

C. Predicate Devices

The subject device is substantially equivalent to the Myshell device cleared under K040498.

D. Device Description

E. Intended Use

The Sedat Myshell Lite is indicated for assisting, manipulating and maintaining a seal around diagnostic/interventional devices with an outside diameter<9F (<.098'') use in interventional angioplasty procedures.

F. Substantial Equivalence

Data were provided which demonstrated the Sedat Myshell Lite, Y connector with a double silicone haemostaticvalve to be substantially equivalent to previously cleared

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devices. The substantial equivalence is based upon equivalence in indications for use, design, material, and function.

G. Summary of Non-Clinical Tests

Bench performance testing was presented.

H. Summary of Clinical Tests (Not Applicable).

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 3 2008

SEDAT c/o Ms. Laetitia Cousin President c/o EXCAELIA™ 8895 Towne Centre Drive, 105-416 San Diego, CA 92122

Re: K080472

SEDAT MYSHELL LITE Regulation Number: 21 CFR 870.4290 Regulation Name: Adapter, stopcock, manifold, fitting, cardiopulmonary bypass Regulatory Class: Class II (two) Product Code: DTL Dated: February 20, 2008 Received: February 21, 2008

Dear Ms. Cousin:

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.

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Page 2 - Ms. Laetitia Cousin

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); 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. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Dma R. Viener

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

510(k) Number (if known):

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Duma R. de Mines

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K080472

Regulation Number and Section

§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.