The MDU5 PLUS Sterile Baq is intended to cover the motordrive 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 MDU5 PLUSTM Sterile Bag is supplied to the user as a sterile device and is intended for single use only. The MDU5 PLUS™ Sterile Bag is intended to cover the motor drive 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. The product consists of a long, narrow bag made of low density polyethylene with one open end. There is a face plate with a covered opening that is attached to the Sterile Bag. Once the Sterile Bag is covering the motordrive unit, the face plate connects to the nose of the motordrive. The face plate is uncovered when the operator is ready to insert the catheter into the motordrive. The bag has been designed to be large enough and flexible enough to cover the motordrive unit while not impeding the 10cm of travel required by the pull-back sled that the motordrive attaches to. The MDU5 PLUSTM Sterile Bag is sufficiently clear as to not impede viewing the motordrive display. The MDU5 PLUSTM Sterile Bag is sold separately as a stand-alone product but is also included as an accessory in the package with each compatible catheter. The materials used in the design of the MDUJ5 PLUS™ Sterile Bag have been selected to be compatible with electron beam sterilization (e-beam sterilization). The MDU5 PLUS™ Sterile Bag is folded and packaged in a Tyvek/Nylon or equivalent medical device packaging that is suitable for E-Beam sterilization.

AI/ML Overview

This is a 510(k) premarket notification for a Class II medical device, the Boston Scientific MDU5 PLUS™ Sterile Bag. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through extensive clinical trials. Therefore, the information provided for acceptance criteria and supporting studies will differ significantly from what would be expected for a novel device, especially one involving AI.

Summary of Acceptance Criteria and Device Performance for MDU5 PLUS™ Sterile Bag

The provided document describes a device intended to maintain a sterile field during intravascular ultrasound procedures. As such, the "acceptance criteria" and "device performance" are primarily related to its physical integrity, sterility, and compatibility.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria / Test Type	Reported Device Performance / Evaluation Method
Physical Integrity & Functionality (Bench/Performance Testing)	Liquid Barrier Evaluation	Bench testing conducted to evaluate physical integrity and functionality at T=0 and T=13 months (Accelerated Aging). Specific results are not detailed, but the submission states this testing was completed.
	Pathogen Penetration Resistance	Bench testing conducted to evaluate physical integrity and functionality at T=0 and T=13 months (Accelerated Aging). Specific results are not detailed, but the submission states this testing was completed.
	Resistance to Penetration by Synthetic Blood	Bench testing conducted to evaluate physical integrity and functionality at T=0 and T=13 months (Accelerated Aging). Specific results are not detailed, but the submission states this testing was completed.
	Resistance to Common Cleaning Agents	Bench testing conducted to evaluate physical integrity and functionality at T=0 and T=13 months (Accelerated Aging). Specific results are not detailed, but the submission states this testing was completed.
	Seal Strength	Bench testing conducted to evaluate physical integrity and functionality at T=0 and T=13 months (Accelerated Aging). Specific results are not detailed, but the submission states this testing was completed.
	Label/Sticker Orientation and Durability	Bench testing conducted to evaluate physical integrity and functionality at T=0 and T=13 months (Accelerated Aging). Specific results are not detailed, but the submission states this testing was completed.
	Interface and Compatibility with Ancillary Devices (e.g., motor drive, catheter insertion)	Designed to be large and flexible enough to cover the motordrive unit without impeding 10cm of travel by the pull-back sled. Face plate connects to the nose of the motordrive. Sufficiently clear to not impede viewing the motordrive display. Bench testing included interface and compatibility. Specific results not detailed, but the submission states this testing was completed.
	User Interface Requirements	Bench testing conducted. Specific results are not detailed, but the submission states this testing was completed.
	Environmental Requirements	Bench testing conducted. Specific results are not detailed, but the submission states this testing was completed.
Sterilization Validation	Sterility Assurance Level (SAL) per ISO 11137-2:2012 (Electron Beam Sterilization)	Sterilization studies (including Bioburden) were conducted according to ISO 11137-2:2012. The device is supplied as sterile.
Packaging Validation	Integrity of packaging configuration after e-beam sterilization, climatic conditioning, and distribution challenge	Tested in accordance with ISO 11607-1 and ISO 11607-2. Test criteria included visual inspections, sterile barrier integrity, and sterile barrier seal strength. Testing was conducted on fully packaged units after being subjected to electron beam sterilization, climatic conditioning, and distribution challenge conditioning. Specific results are not detailed, but the submission states this testing was completed.
Material & Design Equivalence	Comparability to predicate device (CIVCO Poly Ultrasound Transducer Cover, K970513) in material, design, and dimensions	The MDU5 PLUS™ Sterile Bag is made of low-density polyethylene (LDPE), similar to the predicate device. It has a long, narrow bag shape with a faceplate for attachment, similar to the predicate device. The submission states a comparison was made to the predicate device in Section IV (not provided here) and that the design specifications were compared.
Biocompatibility	(Implicit from material selection and intended use of a sterile barrier)	Materials selected were compatible with electron beam sterilization. Not explicitly stated as a separate acceptance criterion with detailed results in this summary, but generally implied for a device of this nature.

Study Proving Device Meets Acceptance Criteria

The study proving the device meets the acceptance criteria is a series of non-clinical performance tests designed to demonstrate substantial equivalence to the predicate device.

Study Title: Not explicitly named, but described as "Performance testing" or "Non-Clinical Data."
Study Type: Comprehensive bench testing, sterilization validation, and packaging validation.
Study Objective: To demonstrate that the MDU5 PLUS™ Sterile Bag is safe and effective for its intended use and substantially equivalent to the predicate device (CIVCO Poly Ultrasound Transducer Cover, K970513).

Specific Information Requested (as applicable for this device type):

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Test Set: The document does not specify the exact sample sizes used for each individual non-clinical test (e.g., how many bags were tested for liquid barrier, how many packages for seal strength). For bench testing, it mentions evaluation "at T=0 and T=13mo AA" (Accelerated Aging), implying multiple time points. For packaging and sterilization, multiple units would have been tested.
Data Provenance: The data is generated from benchtop laboratory testing and validation studies conducted by Boston Scientific Corporation. This is retrospective in the sense that the studies were completed before the 510(k) submission, but it is not "clinical retrospective data." The origin is likely in-house or contracted laboratory testing. No country of origin for patients/data is applicable as this is not a clinical study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This question is not applicable to this type of medical device submission. Ground truth, in the context of diagnostic AI or image analysis, refers to the definitive determination of a condition or measurement, typically established by highly qualified medical experts.
For the MDU5 PLUS™ Sterile Bag, the "ground truth" for acceptance is determined by meeting pre-defined scientific and engineering specifications (e.g., a specific barrier integrity value, a specific seal strength, a specific sterility assurance level). Expert involvement would be in the design and execution of the tests and interpretation of raw data by engineers, microbiologists, and quality control specialists, not in establishing a "ground truth" as medical consensus on a case.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or expert review panels to resolve discrepancies in diagnoses or interpretations among multiple readers. For non-clinical bench and validation testing, results are typically objective measurements against a pre-established standard or specification. Any discrepancies in test results would be resolved through re-testing, investigation of methodology, or quality control procedures, not through a formal expert adjudication process as 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

This question is not applicable. This device is a sterile bag, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. This device is a passive sterile barrier, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on engineering specifications, standardized test methods (e.g., ISO standards), and internal quality control criteria. Examples include:
- Demonstrating a specific level of microbial impermeability.
- Achieving a defined sterility assurance level (e.g., 10^-6 for SAL).
- Meeting pre-established tensile strength for seals or puncture resistance for the material.
- Confirming compatibility with the motor drive unit's physical dimensions and operation.
It is not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

This question is not applicable. This device is a physical product, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable. As no AI model is involved, there is no training set or ground truth for a training set.

Summary

{0}------------------------------------------------

Boston
Scientific

FEB 20 2013

Food and Drug Administration November 6, 2012 Page I of 3

510(k) Summary of Safety and Effectiveness Boston Scientific Corporation MDU5 PLUS TM Sterile Bag

Submitted By:	Boston Scientific Corporation47215 Lakeview BoulevardFremont, CA 94538
Contact Person:	Lori R. SmithSr. Regulatory Affairs SpecialistTel: (510) 624-1698Fax: (510) 624-2569lori.smith@bsci.com
Date Prepared:	November 6, 2012
Proprietary Name:	MDU5 PLUST™ Sterile Bag
Common Name:	Sterile Cover
Classification Name:	Transducer, Ultrasonic, Diagnostic (accessory)
Device Classification/Product Code:	Class II, 21 CFR 892.1570 / ITX

Predicate Device:

The MDU5 PLUSTM Sterile bag is substantially equivalent to the following device:

Product	510(k)	Clearance Date
CIVCO Poly Ultrasound Transducer Cover	K970513	June 20, 1997

Description of the Device:

{1}------------------------------------------------

Food and Drug Administration November 6, 2012 Page 2 of 3

is uncovered when the operator is ready to insert the catheter into the motordrive. The bag has been designed to be large enough and flexible enough to cover the motordrive unit while not impeding the 10cm of travel required by the pull-back sled that the motordrive attaches to. The MDU5 PLUSTM Sterile Bag is sufficiently clear as to not impede viewing the motordrive display.

The MDU5 PLUSTM Sterile Bag is sold separately as a stand-alone product but is also included as an accessory in the package with each compatible catheter. The materials used in the design of the MDUJ5 PLUS™ Sterile Bag have been selected to be compatible with electron beam sterilization (e-beam sterilization). The MDU5 PLUS™ Sterile Bag is folded and packaged in a Tyvek/Nylon or equivalent medical device packaging that is suitable for E-Beam sterilization.

Intended Use / Indications for Use:

The MDU5 PLUS Sterile Bag is intended to cover the motor drive 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 Technology Characteristics and Comparison to Predicate Device:

The Intended Uses for both the MDU5 PLUSTM Sterile Bag and the predicate sterile cover are similar. The MDU5 PLUS™ Sterile Bag is a sterile cover, which is placed over the motordrive unit during ultrasound procedures in order to maintain the sterile field within the catheter lab. The predicate device is also used as a sterile transducer cover, also used to maintain the sterile field during ultrasound procedures. The MDU5 PLUSTM sterile bag is a long, narrow bag made of low-density polyethylene (LDPE), with one closed end and one open end that fits over the motordrive unit and attaches, via a faceplate, to the nose of the motordrive unit. The predicate sterile cover is also made of LDPE and is the same shape as the MDU5 PLUSTM sterile bag, with similar dimensions. The predicate device is also installed over the motordrive unit in a similar fashion, using a ring-type faceplate to attach to the nose of the motordrive. MDU5 PLUSTM sterile bag is sold as a sterile device to the end user as is the predicate device. Both the predicate device and the MDU5 PLUSTM sterile bag can be supplied as a stand-alone device as well as packaged as an accessory to compatible catheters.

In establishing substantial equivalence to the predicate device, Boston Scientific compared the material, design specifications and indications for use of the subject and predicate devices previously cleared in K970513 (cleared June 20, 1997). Additionally, performance testing has been completed for the subject device. The performance testing and device comparison demonstrate that the subject device is substantially equivalent to the predicate device, and is safe and effective for its intended use.

{2}------------------------------------------------

Food and Drug Administration November 6, 2012 Page 3 of 3

Refer to the Predicate Device Comparison Table, located in Section IV, Proposed and Predicate Device Comparison.

Non-Clinical Data

Determination of substantial equivalence is based on an assessment of non-clinical performance data. Non-clinical data includes Bench/Performance, Sterilization, Microbiology and Packaging tests, which were conducted on the subject device.

Bench/Performance Testing:

Bench testing was conducted to evaluate the physical integrity and functionality of the MDUJ5 PLUS™ Sterile Bag at T=0 and T=13mo AA. Test criteria includes liquid barrier evaluation, pathogen penetration resistance and resistance to penetration by synthetic blood, resistance to common cleaning agents, seal strength, label/sticker orientation and durability, interface and compatibility with ancillary devices, user interface requirements and environmental requirements.

Sterilization Validation:

Sterilization studies (including Bioburden) were conducted for the MDU5 PLUSTM Sterile Bag according to ISO 11137-2:2012.

Packaging Validation

The integrity of the packaging configuration was tested in accordance with ISO 11607-1 and ISO 11607-2. Testing was conducted on fully packaged units after being subjected to electron beam sterilization, climactic conditioning, and distribution challenge conditioning. Test criteria included visual inspections. sterile barrier integrity and sterile barrier seal strength.

Clinical Data

No clinical or animal data are included in this submission

Conclusion

The MDU5 PLUS™ Sterile Bag is substantially equivalent to the predicate CIVCO Sterile cover (K970513). The MDU5 PLUS™ test results support the determination of substantial equivalence to the predicate device, and confirm the device is safe and . effective for its intended use.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

February 20, 2013

Boston Scientific Corporation c/o Ms. Lori R. Smith Sr. Regulatory Affairs Specialist 47215 Lakeview Boulevard Fremont, CA 94538

Re: K123424

Trade/Device Name: MDU5 PLUS Sterile Bag Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: Class II Product Code: ITX Dated: November 6, 2012 Received: November 30, 2012

Dear Ms. Smith:

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. Iisting 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 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

{4}------------------------------------------------

Page 2 - Ms. Lori Smith

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

FDA

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

for

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): K123424

Device Name: MDU5 PLUS Sterile Bag

Indications for Use:

Prescription Use X (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 In Vitro Diagnostics and Radiological Health (OIR)

FDA

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

Page 1 of 1

Regulation Number and Section

N/A