DS CASSETTE

K053173 · Konica Minolta Medical & Graphic, Inc. · IXA · Dec 15, 2005 · Radiology

Device Facts

• Record ID: K053173
• Device Name: DS CASSETTE
• Applicant: Konica Minolta Medical & Graphic, Inc.
• Product Code: IXA · Radiology
• Decision Date: Dec 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1850
• Device Class: Class 2

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.

Device Story

DS Cassette is a light-proof enclosure for radiographic film used in diagnostic x-ray procedures. Device holds film in close contact with x-ray intensifying screens during exposure. Available in various metric and imperial sizes. Exposed film is removed manually or automatically for processing in compatible x-ray film processors (e.g., Konica DS-7). Used in clinical radiology settings by technicians or clinicians. Provides physical support and protection for film during imaging; facilitates subsequent chemical or automated processing.

Clinical Evidence

No clinical data. Bench testing only; device conforms to ISO 4090:2001.

Technological Characteristics

Radiographic film cassette; conforms to ISO 4090:2001. Available in multiple sizes ranging from 15x30cm to 14x17inch. Mechanical light-proof enclosure design. No electronic components or software.

Indications for Use

Indicated for use in diagnostic x-ray procedures to hold radiographic film in contact with intensifying screens and provide a light-proof enclosure. Not for mammography use.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Konica Mammography Cassettes; Models CM and CM DS-7 (K963914)

Reference Devices

• Konica DS-7 automatic X-ray film processor (K931316)

Submission Summary (Full Text)

{0}------------------------------------------------

# 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: [phone] Fax: [phone]

## 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.

{1}------------------------------------------------

#### 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.

{2}------------------------------------------------

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.

{3}------------------------------------------------

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 [phone] or [phone] 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

{4}------------------------------------------------

# 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