(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.
§ 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.