(31 days)
The DS Cassette is intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film. It is not intended for mammography use.
The DS Cassette is intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film. The cassette is in a family of film sizes. The sizes are as follows; 35 x 43cm, 35 x 35cm, 40 x 40cm, 30 x 40cm, 30 x 35cm, 24 x 30cm, 24 x 24cm, 20 x 40cm, 18 x 43 cm, 18 x 24cm, 15 x 40cm, 15 x 30cm, 14 x 17inch, 14 x 14inch, 12 x 15inch, 11 x 14inch, 10 x 12inch, 8 x 10inch, 6.5 x 8.5inch, 7 x 17inch. The exposed film is taken out from the Cassette manually or automatically for processing by X-ray film processor such as Konica DS-7 automatic X-ray film processor, 510(k) number K931316.
The provided text is a 510(k) Summary for a radiographic film cassette. This type of document is for a medical device and typically demonstrates substantial equivalence to a predicate device, rather than presenting a study proving a device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, or AUC as might be done for AI/ML-based diagnostic devices.
Therefore, much of the requested information (like sample size for test/training set, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and effect sizes) is not applicable to this type of device and submission. The submission focuses on product specifications and conformance to an existing standard.
Here's the information that can be extracted or deduced from the provided document:
Acceptance Criteria and Device Performance for DS Cassette
| Criterion | Reported Device Performance |
|---|---|
| Intended Use Conformance | The DS Cassette is intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film. It is not intended for mammography use. |
| Conformance to ISO 4090:2001 (Standard) | The DS Cassette conforms to ISO 4090:2001. A certification by the manufacturer, Okamoto Manufacturing Co., Ltd., is attached as proof. |
| Substantial Equivalence to Predicate | The DS Cassette is substantially equivalent to Konica Mammography Cassettes; Models CM and CM DS-7 (510(k) number: K963914) in terms of technological characteristics and intended use (excluding mammography for the DS Cassette). |
| Device Specifications (Physical Sizes) | Available in various sizes: 35x43cm, 35x35cm, 40x40cm, 30x40cm, 30x35cm, 24x30cm, 24x24cm, 20x40cm, 18x43cm, 18x24cm, 15x40cm, 15x30cm, 14x17inch, 14x14inch, 12x15inch, 11x14inch, 10x12inch, 8x10inch, 6.5x8.5inch, 7x17inch. Product specifications by the manufacturer are attached. |
| Light-proof Enclosure | Designed to provide a light-proof enclosure for direct exposure of radiographic film. |
| Film Contact | Designed to hold a radiographic film in close contact with an x-ray intensifying screen. |
Study Information (based on available text):
- Sample size used for the test set and the data provenance: Not applicable. This submission doesn't describe a clinical "test set" in the context of performance metrics for an AI/ML device. It relies on design specifications and conformance to standards.
- 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 a passive device (cassette), not an AI/ML diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable in the context of diagnostic accuracy. The "ground truth" here is adherence to design specifications, the physical characteristics of the device, and conformance to the ISO standard.
- The sample size for the training set: Not applicable. This device does not involve training data as it is not an AI/ML algorithm.
- How the ground truth for the training set was established: Not applicable.
Summary of Acceptance Criteria and Evidence from Text:
The acceptance criteria for the DS Cassette are primarily based on its physical characteristics, intended use, and conformance to an international standard, rather than performance metrics derived from clinical studies with ground truth. The study that "proves the device meets the acceptance criteria" is implicitly the design and manufacturing process certified to meet ISO 4090:2001 and the demonstration of substantial equivalence to a previously cleared predicate device (Konica Mammography Cassettes; Models CM and CM DS-7, K963914) for its non-mammography intended use. The submission includes a "certification by a manufacturer of the cassette" as evidence of compliance.
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DEC 1 5 2005 510(k) Summary
K0531/23
as required by 807.92
1. Company Identification
KONICA MINOLTA MEDICAL & GRAPHIC, INC. 2970 Ishikawa-machi Hachioji-shi, Tokyo 192-8505, Japan Tel: +81-426-60-9607 Fax: +81-426-60-9588
2. Official Correspondent
Masafumi Saito(Mr.) Department TS Advanced Technology Division R & D Center
3. Date of Submission
November 4th, 2005
4. Device Trade Name
DS Cassette
5. Common Name
Radiographic film cassette
6. Classification
Radiographic film cassette, Class II per 21 CFR 892. 1850.
7. Applicable Standard
Voluntary standard to which the DS Cassette conforms is: ISO 4090:2001
A certification by a manufacturer of the cassette, Okamoto Manufacturing Co., Ltd. (Registration Number: 3004768771) is attached.
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8. Intended Use
The DS Cassette is intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film. It is not intended for mammography use.
9. Description of Device
The DS Cassette is intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film. The cassette is in a family of film sizes. The sizes are as follows;
35 x 43cm, 35 x 35cm, 40 x 40cm, 30 x 40cm, 30 x 35cm, 24 x 30cm,
24 x 24cm, 20 x 40cm, 18 x 43 cm, 18 x 24cm, 15 x 40cm, 15 x 30cm,
14 x 17inch, 14 x 14inch, 12 x 15inch, 11 x 14inch, 10 x 12inch, 8 x 10inch, 6.5 x 8.5inch, 7 x 17inch
The exposed film is taken out from the Cassette manually or automatically for processing by X-ray film processor such as Konica DS-7 automatic X-ray film processor, 510(k) number K931316.
For more information, please refer to the attachments.
10. Substantial Equivalence to Predicate Device
The DS Cassette is substantially equivalent to Konica Mammography Cassettes; Models CM and CM DS-7, 510(k) number: K963914.
11. Technological Characteristics
The technological characteristics of the DS Cassette are the same as those of the predicate device. The product specifications by a manufacturer of the cassette, Okamoto Manufacturing Co., Ltd. (Registration Number: 3004768771) is attached.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Shinichi Yamanaka Progress Secretary Cosmos Corporation 319 Akeno, Obata-cho, Ise-shi Mie-ken, 519-0501 JAPAN
DEC 1 5 2005
Re: K053173 Trade/Device Name: DS Cassette Regulation Number: 21 CFR 892.1850 Regulation Name: Radiographic film cassette Regulatory Class: II Product Code: IXA
Dated: November 4, 2005 Received: November 15, 2005
Dear Mr. Yamanaka:
We have reviewed your Section 510(k) premarket notification of intent to market the device is to we have reviewed your occurity profity prohstantially equivalent (for the indications for use stated in above and have determined the do not icate devices marketed in interstate commerce prior to the enclosure) to regally marketed predical Device Amendments, or to devices that have been May 26, 1970, the Claculicin date of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordance with the proval application (PMA). You may, therefore, market the do not require approval of a premance approvisions of the Act. The general controls provisions of the Act device, subject to the general controls provisions 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 If your device is classified (36€ above) hits major regulations affecting your regulations affecting your Approval), It may be subject to such ademond ventions, Title 21, Parts 800 to 898. In addition, FDA device can of round in the cenents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that 112X's issumes of a vith other requirements of the Act or any FOA has made a decemmation mar your de received agencies. You must comply with all the r caeral statues and regulations administer 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) ( 2 ) CFR Part 801); 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)
. I wall This letter will allow you to ocgin maketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalevise and thus premarket notification. The PDA mading of Sabstantial of the and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CIFR Part 801), please If you desire specific advice for your device on our laboring ong 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 Also, please note the regulation entitled, "finsonation on your responsibilities under the Act from the 807.97). You may obtain other general information on your er 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. Brigdon
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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Indications for Use
510(k) Number (if known) : K053173
: DS Cassette Device Name
Indications For Use:
The DS Cassette is intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film. It is not intended for mammography use.
Prescription Use (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 Device Evaluation (ODE)
Daniel K. Lipton
5 1288 14:3000
Page 1 of
§ 892.1850 Radiographic film cassette.
(a)
Identification. A radiographic film cassette is a device intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.