(88 days)
The TDK Medical Grade CD-R is a storage medium used for picture archiving and exchange of recordable information. The TDK Medical Grade CD-R is a multisession disc with 650MB capacity, which is used in conjunction with cardio review stations and mini review stations that accept this type of media. TDK Medical Grade CD-R media provides the following capabilities; acquisition, exchange, display, review and archiving.
The TDK Medical Grade CD-R is a storage medium used for picture archiving and exchange of recordable information. The TDK Medical Grade CD-R is a multisession disc with 650MB capacity, which is used in conjunction with cardio review stations and mini review stations that accept this type of media. TDK Medical Grade CD-R media provides the following capabilities; acquisition, exchange, display, review and archiving. The TDK Medical Grade CD-R conforms to ISO 9002, Orange Book, Part II.
This is a 510(k) clearance letter and Indications for Use statement for a medical grade CD-R, not a study proving device performance against acceptance criteria for an AI/ML medical device. Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set details) is not applicable to this document.
The document states that the TDK Medical Grade CD-R is "substantially equivalent" to devices marketed prior to May 28, 1976. This is a regulatory finding primarily based on the device's intended use and technological characteristics being comparable to a legally marketed predicate device, rather than a performance study as would be conducted for a novel AI/ML algorithm.
The "Indications for Use" section describes the device's purpose: "a storage medium used for picture archiving and exchange of recordable information... used in conjunction with cardio review stations and mini review stations that accept this type of media. TDK Medical Grade CD-R media provides the following capabilities; acquisition, exchange, display, review and archiving." It also notes conformance to "ISO 9002, Orange Book, Part II." These are specifications and standards the product meets, not performance metrics derived from a clinical study.
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utar newith Servace
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 1997
Kovo Yokoi Executive Vice President TDK Electronics Corporation of America 12 Harbor Park Drive Port Washington, NY 11050
Re: K971848
TDK Medical Grade CD-R PACS Accessory Dated: May 19, 1997 Received: May 19, 1997 Unclassified Product Code: 90 LMB
Dear Mr. Yokoi:
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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and
through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your of vice in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marked 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 question 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/cdrh/dsmamain.html".
Sincerely yours.
h. 7liau Yu
Lilian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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K11848
Page I of I
510(k) Number (if known):
Device Name: TDK Medical Grade CD-R
Classification Panel:
Indications for Use:
The TDK Medical Grade CD-R is a storage medium used for picture archiving and exchange of recordable information. The TDK Medical Grade CD-R is a multisession disc with 650MB capacity, which is used in conjunction with cardio review stations and mini review stations that accept this type of media. TDK Medical Grade CD-R media provides the following capabilities; acquisition, exchange, display, review and archiving.
The TDK Medical Grade CD-R conforms to ISO 9002, Orange Book, Part II.
TDK Medical Grade CD-R should be used only by persons thoroughly trained in the use of the specific picture archiving and communication system being used, with special attention to training in the use of the write/read hardware.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Bryson
(Division Sign-Off) Division of Reproductive, Abdominal, E and Radiological Devi
510(k) Number K77
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use
§ 892.2010 Medical image storage device.
(a)
Identification: A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.