(231 days)
The Scout catheter is intended for the intravascular ultrasound examination of coronary arteries. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
M2440A intravascular ultrasound imaging catheter has equivalent functionality to the predicate Boston Scientific catheters now cleared for use with M2400A: acoustic output for the M2440A operating on the M2400A is within FDA limits. The pullback functionality incorporated into the M2440A catheter and the M2401B PIU are equivalent to the predicate Boston Scientific catheters and pullback devices listed above.
This submission is a 510(k) premarket notification for the Hewlett-Packard Scout Catheter. It claims substantial equivalence to predicate devices and focuses on modifications to patient contact materials and the ergonomic configuration of the motorized pullback system. As a 510(k), this document primarily focuses on demonstrating substantial equivalence to pre-existing devices, rather than establishing acceptance criteria and conducting a detailed study with specific performance metrics against those criteria in the way a de novo or PMA submission might.
Therefore, the requested information, which is typical for AI/ML device submissions involving performance metrics and clinical studies, is not explicitly available in this 510(k) submission.
Here's why and what information can be extracted:
-
Acceptance Criteria and Reported Performance: A 510(k) for a device like a catheter typically relies on demonstrating that the new device performs "as intended" and is as safe and effective as the predicate. This often involves bench testing (e.g., biocompatibility, physical properties, acoustic output) to confirm it meets engineering specifications, rather than clinical performance metrics like sensitivity/specificity for a diagnostic AI. The document states:
- "Submission includes acceptable biocompatibility and bench testing results for all changes to design and materials."
- "acoustic output for the M2440A operating on the M2400A is within FDA limits."
- "The pullback functionality incorporated into the M2440A catheter and the M2401B PIU are equivalent to the predicate Boston Scientific catheters and pullback devices listed above."
- "M2440A is substantially equivalent to the predicate 6) Boston Scientific catheters."
-
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied from 510(k) context) | Reported Device Performance (as stated in 510(k)) |
|---|---|
| Biocompatibility of new patient contact materials | "acceptable biocompatibility...results for all changes to design and materials." |
| Acoustic output within FDA limits | "acoustic output for the M2440A operating on the M2400A is within FDA limits." |
| Equivalent functionality to predicate devices for intravascular ultrasound | "equivalent functionality to the predicate Boston Scientific catheters now cleared for use with M2400A" |
| Equivalent functionality of motorized pullback system | "The pullback functionality incorporated into the M2440A catheter and the M2401B PIU are equivalent to the predicate Boston Scientific catheters and pullback devices" |
| Substantial equivalence to predicate devices | "M2440A is substantially equivalent to the predicate 6) Boston Scientific catheters." |
The 510(k) process typically doesn't require the detailed breakdown of clinical study designs (sample size, ground truth, expert qualifications, etc.) that would be expected for novel AI/ML devices or higher-risk devices requiring PMA. The "proof" here is primarily based on engineering and biocompatibility testing, along with comparison to a legally marketed predicate device.
Given the nature of this 510(k) for an intravascular ultrasound catheter, the following information is not present and would not typically be required for this type of submission:
- Sample size used for the test set and the data provenance: Not applicable in the context of a "test set" for performance metrics as you would see with AI. The testing would be bench/biocompatibility.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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. This is not an AI device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical performance claims in this submission. For biocompatibility, the "ground truth" would be established by industry standards and validated testing protocols.
- The sample size for the training set: Not applicable as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
{0}------------------------------------------------
JUL 1 4 1998
Hewlett-Packard Scout Catheter
510(k) Summary of Safety and Effectiveness
(per 21 CFR 807.92)
- l) Submitter's Name / Contact Person: Rob Butler Address: 3000 Minuteman Road, Andover, MA 01810 Telephone Number: (978) 659-2785 Date Summary was prepared: November 17, 1997
Trade Name 2)
Model Number
33
Scout 3.2F/45 MHz Coronary Imaging Catheter .014" Compatible M2440A-014 Scout 3.2F/45 MHz Coronary Imaging Catheter .018" Compatible M2440A-018 M240IB Scout Imaging Catheter Patient Interface Unit (PIU)
Common Name: Ultrasonic Diagnostic Catheter
| Classification Name | CFR Number | Product Code |
|---|---|---|
| Diagnostic Ultrasound Transducer | 21 CFR 892.1570 | 90 ITX |
| Diagnostic Intravascular Catheter | 21 CFR 870.1200 | 74 DQO |
Identification of Predicate Devices: 3)
| Manufacturer | Device | 510(k) Number |
|---|---|---|
| Boston Scientific | MicroView II/MicroRail II 3.2/30 MHz | K942231 |
| Boston Scientific | Sonicath 3.5F Ultrasound Imaging Catheter | K913890 |
| Boston Scientific | Automatic Pullback Device | K933517 |
| Boston Scientific | CVIS Catheter Pullback Device | K921879 |
4) Description of the device or modification being submitted for premarket approval.
Functionality: M2440A intravascular ultrasound imaging catheter has equivalent functionality to the predicate Boston Scientific catheters now cleared for use with M2400A: acoustic output for the M2440A operating on the M2400A is within FDA limits. The pullback functionality incorporated into the M2440A catheter and the M2401B PIU are equivalent to the predicate Boston Scientific catheters and pullback devices listed above.
Scientific Concepts: same as existing intravascular ultrasound imaging catheters and pullback devices operating on the M2400A Intravascular Ultrasound System.
Hewlett-Packard Confidential
{1}------------------------------------------------
Hewlett-Packard Scout Catheter
Significant Characteristics of the Modification: new patient contact materials for M2440A Intravascular Ultrasound imaging catheter. New ergonomic configuration for the motorized pullback system.
Statement of Intended Use: same as intended use for the predicate devices: 5) intravascular ultrasound examination of the coronary arteries.
Predicate Device Comparison: M2440A is substantially equivalent to the predicate 6) Boston Scientific catheters. The functionality of the motorized pullback integrated into the M2401 B patient interface unit when operated with the M2440A catheter is substantially equivalent to the predicate device intended use . Submission includes acceptable biocompatibility and bench testing results for all changes to design and materials.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, serif font. The text is centered on the image and is the only element present.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL
Rob Butler Regulatory Engineer Hewlett-Packard Company Imaging Systems 3000 Minuteman Rd. Andover, MA 01810
Re:
K974457 Scout 3.2/45 MHz Coronary Imaging Catheters Dated: June 22, 1998 Received: June 23, 1998 Regulatory class: II 21 CFR 892.1560/Procode: 90 IYO 21 CFR 892.1570/Procode: 90 ITX
Dear Mr. Butler:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/odrh/dsmaldsmamain.html".
Sincerely yours,
William Yin
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Attachment E: Scout Indications for Use Form
FDA Diagnostic Ultrasound Device Indications Statement
510(k) Number (if known): K974457
Device Name(s): M2440A-018/M2440A-014 Scout 3.2F/45 MHz Coronary Imaging Catheter(s)
M2401B Patient Interface Unit
The Scout catheter is intended for the intravascular ultrasound examination of Intended Use: coronary arteries. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | |
| Fetal | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | |
| Abdominal | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Intra-operative(specify) | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Intra-OperativeNeurological | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Pediatric | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Small Organ(prostate) | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Neonatal Cephalic | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Adult Cephalic | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Cardiac Adult | NA | X | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Cardiac Pediatric | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Trans-esophageal | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Trans-rectal | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Trans-vaginal | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Intra-Luminal | NA | X | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Trans-urethral | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Peripheral Vessel | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Laparoscopic | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Musculo-SkeletalConv. | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Musculo-SkeletalSuperf. | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Other (specify) | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
Other Indications or Modes: None
1
David A. Hygum
(Division Sign-Off)
Hewlett-Packard Confidential
Prescription Use . (Per 21 CFR 801.109) Division of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.