The sterile bag is intended to cover the motordrive/sled assembly during intravascular ultrasound procedures to maintain the sterile field and prevent transfer of microorganisms, body fluids and particulate material to the patient and healthcare worker.

Device Description

The Permanent Sled Bag is a sterile, single-use device. It will be used with the iLab Ultrasound Imaging System. It is intended to cover the MDU5 PLUS motordrive/permanent sled assembly during intravascular ultrasound procedures and prevent transfer of mmicroorganisms, body fluids and particulate material to the patient and healthcare worker. The device consists of a long, narrow bag made of low density polyethylene and is e-beam sterilized. The bag is folded and packaged in a Tyvek®/Nylon or equivalent medical device packaging suitable for e-beam sterilization. The Permanent Sled Bag will not impede the 10cm travel of the sled. There is a faceplate that is attached to the Permanent Sled Bag that attaches to the MDU5PLUS motordrive. The Permanent Sled Bag is sufficiently clear as to not impede viewing of the MDU5PLUS display. The Permanent Sled Bag must not interfere with the installation of the MDU5PLUS/permanent sled assembly. The Permanent Sled Bag will be available as a standalone product or with IVUS catheters.

AI/ML Overview

The provided document is a 510(k) Summary for the "Permanent Sled Bag," a sterile cover for an intravascular ultrasound motordrive/sled assembly. It does not describe a study involving software performance testing, AI, human readers, or medical image analysis. Instead, it focuses on non-clinical, bench/performance testing to establish substantial equivalence to a predicate device.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device meets acceptance criteria are not applicable to this document.

However, I can extract the information relevant to the non-clinical testing performed for this device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test)	Reported Device Performance (Result)
End Seal Strength	Passed
Tabs/Stickers	Passed
Grip Points	Passed
Functional Efficiency	Passed
Display Viewing	Passed
MDU5PLUS Movement	Passed
Unit Compatibility	Passed
System Preparation with Sled	Passed
RoHS Compliance	Passed

Note: The document states "All predetermined acceptance criteria were met during design verification as specified in the requirements of 21 CFR 820.30." For these bench tests, the criteria are implied to be "Pass" or "Fail" as indicated.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated for each bench test. The nature of these tests (e.g., "End Seal Strength," "Display Viewing") suggests samples of the manufactured device were tested, but the number is not quantified in this summary.
Data Provenance: Not applicable in the context of clinical data. These are results from in-house bench/performance testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The "ground truth" for these engineering/performance tests is based on the specific design specifications and industry standards for mechanical and material properties, not expert clinical interpretation.

4. Adjudication method for the test set:

Not applicable. The tests are "Pass/Fail" against pre-defined engineering and performance specifications.

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, an MRMC comparative effectiveness study was not done. This device is a sterile bag, not an AI or imaging diagnostic tool that would involve human readers.

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. This device is a physical sterile cover, not an algorithm.

7. The type of ground truth used:

The "ground truth" for these tests is the device's conformance to its engineering specifications and functional requirements (e.g., maintaining sterility, not impeding movement, being sufficiently clear). These are objective measurements rather than a clinical ground truth.

8. The sample size for the training set:

Not applicable. This device is not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 22, 2015

Boston Scientific % Mr. George Prendergast Senior Regulatory Affairs Specialist 47215 Lakeview Blvd. FREMONT CA 94538

Re: K152403

Trade/Device Name: Permanent Sled Bag Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: August 21, 2015 Received: August 25, 2015

Dear Mr. Prendergast:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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 (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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Oolo

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K152403

Device Name Permanent Sled Bag

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary Boston Scientific Corporation Permanent Sled Bag

This 510(k) Summary is provided in this Premarket Notification in accordance with requirements of the Safe Medical Device Act (SMDA) of 1990. The content is submitted in conformance with 21 CFR Part 807.92.

Submitted By:	Boston Scientific Corporation47215 Lakeview Blvd.Fremont, CA. 94538
Contact Person:	George J. PrendergastSenior Regulatory Affairs SpecialistTel: 510-624-1634Fax: 510-440-7698George.Prendergast@bsci.com
Date: Prepared:	August 21, 2015
Proprietary Name:	Permanent Sled Bag
Common Name:	Sterile Cover
Classification Name:	Class IITransducer, Ultrasonic, Diagnostic (accessory)21 CFR Part 892.1570 (90ITX)Radiology/Cardiology Panel
Product Code:	90ITX

Predicate Device:

Product	510(k)	Clearance Date
MDU5 PLUS Sterile Bag	K130243	March 1, 2013

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Description of the Device:

Tyvek® is a registered trademark of E.I du Pont de Nemours

Intended Use / Indications For Use:

Technological Characteristics:

The modified Permanent Sled Bag employs the same Indications for Use, fundamental scientific technology, and principle of operation as its predicate device.

Determination of Substantial Equivalence: Non-Clinical Data

Determination of substantial equivalence is based in part on an assessment of non-clinical performance data. Non-clinical data included design verification (Bench/Performance Testing, Sterilization Validation and Microbiological Product Evaluation) of

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the proposed Permanent Sled Bag. All predetermined acceptance criteria were met during design verification as specified in the requirements of 21 CFR 820.30. The design verification testing results did not raise different questions of safety and effectiveness associated with changes made to the device.

Bench/Performance Testing

Design verification bench/performance testing included the following tests which passed based on a Pass/Fail basis: End Seal Strength, Tabs/Stickers, Grip Points, Functional Efficiency, Display Viewing, MDU5PLUS Movement, Unit Compatibility, System Preparation with Sled, RoHS Compliance.

Non-Clinical Testing Conclusion

The non-clinical testing demonstrates the proposed device is as safe and as effective and performs as well as or better than the legally marketed device.

Clinical Data / Animal Data:

No clinical or animal data were generated to support this submission.

Conclusion:

The proposed modifications to the Permanent Sled Bag described in this submission are substantially equivalent to the predicate device. The proposed modifications and labeling are not substantial changes. They do not significantly affect the safety and efficacy of the device.

Regulation Number and Section

N/A