(7 days)
ACHIEVA 1.5T & INTERA 1.5T family consists of diagnostic devices that produce crosssectional images, spectroscopy images and/or spectra in any orientation of the internal structure of the whole body. These images when interpreted by a trained physician yield information that may assist in diagnosis.
The ACHIEVA 1.5T & INTERA 1.5T family is the successor of the predicate ACHIEVA family release 1-series. The design of ACHIEVA 1.5T & INTERA 1.5T family is based on the same software platform and hardware technology as its predicate device. All MR system parts of the ACHIEVA 1.5T & INTERA 1.5T family have the same appearance. The new gradient configurations are more powerful than their previous versions available on the Intera 1.5T and Achieva 1.5T systems. Especially the slewrate of these systems is improved. This improved slewrate allows for shorter echo times (TE), Echo Spacing (ES) and repetition times (TR).
The provided document is a 510(k) summary for the Philips ACHIEVA 1.5T & INTERA 1.5T family of Magnetic Resonance Diagnostic Devices (MRDD). This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth are not applicable (N/A) because they are typically part of a de novo submission or a premarket approval (PMA) application, not a 510(k) for substantial equivalence based on technology upgrades.
Here's a breakdown of the information that can be extracted or that is N/A based on the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Metric | Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Substantial Equivalence to Predicate Device (K043147) | Equivalent design, software platform, and hardware technology. No new risks. | Based on the same software platform and hardware technology as its predicate device. All MR system parts have the same appearance. New gradient configurations are more powerful, allowing for shorter echo times (TE), Echo Spacing (ES), and repetition times (TR). | The core "acceptance criteria" here is substantial equivalence to the predicate, which the submission asserts is met due to similar fundamental design and technology, with improvements in gradient configurations. |
| Safety and Effectiveness | No other risks beyond those indicated for the predicate device. | Does not induce any other risks than already indicated for its predicate device with the same safety and effectiveness. | This is a declarative statement of safety and effectiveness being equivalent to the predicate. |
2. Sample size used for the test set and the data provenance:
- N/A. This submission leverages the substantial equivalence pathway, not a clinical trial with a distinct test set to evaluate performance against specific criteria. The comparison is primarily against the predicate device's existing clearance and safety profile.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. As no new clinical study with a test set for diagnostic accuracy was conducted for this 510(k), there wasn't a process described for establishing clinical ground truth for a test set. The "ground truth" implicitly relies on the established safety and effectiveness of the existing predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No clinical test set requiring adjudication was used as part of this substantial equivalence submission.
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:
- N/A. This device (Magnetic Resonance Diagnostic Device) is a foundational imaging modality, not an AI-assisted diagnostic tool. No MRMC study or AI-related effectiveness study was performed or described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This device is an imaging hardware system, not an algorithm, and thus standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is the performance and safety record of the predicate device (ACHIEVA family release 1-series, K043147). The submission asserts that the new device shares the same fundamental technology and does not introduce new safety or effectiveness concerns.
8. The sample size for the training set:
- N/A. This is a hardware and software upgrade to an existing MRI system. The concept of a "training set" as understood in machine learning/AI is not applicable here. The development would involve engineering design, testing, and validation against technical specifications rather than a data-driven training process in the AI sense.
9. How the ground truth for the training set was established:
- N/A. As explained above, the concept of a "training set" with established ground truth is not relevant to this type of device submission.
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AUG 2 - 2005
APPENDIX Va
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The following information is being submitted in accordance with the requirements of 21 CFR 807.92.
General information
| Company Name: | Philips Medical Systems Nederland BV |
|---|---|
| Address: | Veenpluis 4-6Best, Netherlands, 5684 PC |
| Registration No.: | 1217116 |
| Contact person: | Lynn HarmerManager, regulatory SubmissionsTel: (425) 487-7312Fax: (425) 487-8666Lynn.Harmer@Philips.com |
| Date Prepared: | July 12, 2005 |
| Device (Trade) Name: | ACHIEVA 1.5T & INTERA 1.5T family |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Regulatory Number: | 892.1000 |
| Classification: | Class II |
| Product code: | LNH |
| Performance standards: | NEMA voluntary standards, FDA MR Diagnostic DeviceGuidance, UL and IEC 601 appropriate safety standardsand/or draft standards are used. |
Predicate Device(s):
The Philips Medical Systems ACHIEVA 1.5T & INTERA 1.5T are the successors of the already cleared (predicate device) ACHIEVA family release 1-series (ref. K043147).
Indications for use:
The ACHIEVA 1.5T & INTERA 1.5T consists of diagnostic devices that produce crosssectional images, spectroscopy images and/or spectra in any orientation of the internal structure of the whole body. These images when interpreted by a trained physician yield information that may assist in diagnosis.
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Device description
The ACHIEVA 1.5T & INTERA 1.5T family is the successor of the predicate ACHIEVA family release 1-series.
The design of ACHIEVA 1.5T & INTERA 1.5T family is based on the same software platform and hardware technology as its predicate device. All MR system parts of the ACHIEVA 1.5T & INTERA 1.5T family have the same appearance.
The new gradient configurations are more powerful than their previous versions available on the Intera 1.5T and Achieva 1.5T systems. Especially the slewrate of these systems is improved. This improved slewrate allows for shorter echo times (TE), Echo Spacing (ES) and repetition times (TR).
General Safety and Effectiveness
The ACHIEVA 1.5T & INTERA 1.5T family does not induce any other risks than already indicated for its predicate device with the same safety and effectiveness.
Substantial Equivalence
It is the opinion of Philips Medical Systems that the Philips ACHIEVA 1.5T & INTERA 1.5T family is substantially equivalent to its predicate device ACHIEVA family.
End
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is a stylized image of a bird, possibly an eagle, with three lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Philips Medical Systems Nederland BV % Mr. Marc M. Mouser Senior Project Engineer/Reviewer UL Conformity Assessment Services Underwriters Laboratories, Inc. West Coast Division, Camas Office 2600 N.W. Lake Road CAMAS WA 98607-8542
Re: K052013
AUG 2 - 2005
Trade/Device Name: Achieva 1.5T & Intera 1.5T Family Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: July 22, 2005
Received: July 26, 2005
Dear Mr. Mouser:
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 (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 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); 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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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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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APPENDIX Vb
Indication for use
510(k) Number (if known):
1052013
Device Name:
ACHIEVA 1.5T & INTERA 1.5T family
Indication For Use:
ACHIEVA 1.5 & INTERA 1.5T family consists of diagnostic devices that produce cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis
Prescription Use X (Per 21 CFR 801.109)
OR Over-The-Counter Use
( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy brogelon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052013
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.