PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER

K081557 · Jddb Manufacturing, Inc. · IXA · Sep 10, 2008 · Radiology

Device Facts

• Record ID: K081557
• Device Name: PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER
• Applicant: Jddb Manufacturing, Inc.
• Product Code: IXA · Radiology
• Decision Date: Sep 10, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1850
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Portable Supine Patient Support and Cassette Holder is a supine support device intended to lay flat on a flat surface to hold and position a radiographis cassette, also to hold and position a patient for radiographic x-ray exposure. I intended for medical use.

Device Story

Portable, non-ionizing radiographic support device; facilitates scoliosis spine radiography. Components: head support, rectangular cassette holder (94cm x 40.5cm), foot support, removable carbon fiber cover top. Device placed on flat surface; patient positioned supine on carbon fiber top for x-ray exposure. Carbon fiber material ensures radiotranslucency. Used by clinicians in hospitals, orthopedic clinics, and chiropractic offices. Benefits: provides stable patient positioning and cassette alignment for diagnostic imaging.

Clinical Evidence

Bench testing only. Radiotranslucency testing performed on carbon fiber material samples (2.63mm and 2.76mm thickness) to verify compliance with 21 CFR 1020.30(n) Table 2 criteria for tabletop radiolucency (Al equivalence < 1.2mm for stationary or < 1.7mm for movable/articulated).

Technological Characteristics

Portable supine support; carbon fiber construction. Dimensions: 94cm x 40.5cm. Radiotranslucency: < 1.2mm Al equivalent (stationary) or < 1.7mm Al equivalent (movable/articulated). Conforms to ISO 4090:2001. Non-powered, mechanical device.

Indications for Use

Indicated for patients requiring supine positioning for radiographic x-ray exposure of the spine, including scoliosis radiography. Used in children's hospitals, general hospitals, rehabilitation institutions, orthopedic clinics, chiropractic offices, and spine/scoliosis clinics.

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

• Trimax Radiographic Cassette (K980722)

Submission Summary (Full Text)

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# K081557

SEP 1 0 2008

# 1. Company Identification

JDDB Manufacturing, Inc. 446 W. 1280 Place Chicago, Illinois Tel: [phone] Fax: [phone]

# 2. Official Correspondent

Jacquin C. Youngblood-Johnson (Ms.) Post Office Box 277782 Riverdale, Illinois 60827-7782

# 3. Date of Submission

September 2, 2008

# 4. Device Trade Name

Portable Supine Patient Support and Cassette Holder

#### 5. Common Name

Scoliosis Supine Cassette Holder

### 6. Classification

Radiographic film cassette, Class II per CFR 892.1850.

### 7. Applicable Standard

Voluntary standard to which the Portable Supine Patient Support and Cassetti Holder conforms is: ISO 4090:2001

# 8. Intended Use

The Portable Supine Patient Support and Cassette Holder is a supine support device intended to lay flat on a flat surface to hold and position a radiographis cassette, also to hold and position a patient for radiographic x-ray exposure. I intended for medical use.

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# 9. Description of Device

The Portable Supine Patient Support and Cassette Holder is a portable, nonionizing radiation device used for scoliosis radiography of the spine. The device consists of a head support, a rectangular cassette holder (94cm×40.5cm), which will hold the cassette, a foot support, and a removable cover top on top of the cassette holder.

# 10. Substantial Equivalence to Predicate Device

The Portable Supine Patient Support and Cassette Holder is substantially equivalent to Trimax Radiographic Cassette; 510(K) number: K980722.

# 11. Technical Characteristics

The technical characteristics of the Portable Supine Patient Support and Cassette Holder would be the same as those for the predicate device for the cassette. However, the cover top the patient will be positioned on top of, for the radiograph exposure, is made of carbon fiber material. Singled layer of carbon fiber material (2.76mm) moets the radiotranslucency requirements of 21 CFR Ch. 1 1 1020.30 (n) Table 2 (2008) criteria for "Tabletop, movable, without articulated joints" as well as Tabletop, with radiolucent panel having one articulated joint" since it is not greater than 1.7mm Al equivalent. The data also indicates that a single layer does meet the radiotranslucency requirement as "Tabletop, stationary, 'without articulated joints" since it does not exceed 1.2 mm Al equivalent. Data attached for two samples of carbon fiber material. I onl made reference to one sample in this writing because of space.

# 12. Who Will Use Device

11

Children Hospitals, Regular Hospitals, Rehabilitation Institutions, Hospitals for Crippled Children, Orthopedic Clinics, Chiropractic Offices, and Spine/ Scolios 111, Clinics.

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| | K & S Associates, Inc. |
|--|------------------------|
|--|------------------------|

Image /page/2/Picture/1 description: The image shows a document with the text "Test #: D080514" and "Test Date 07-Mar-08" at the top. Below the text is a black and white image of what appears to be a mechanical device. The device has a cylindrical shape with various attachments and components. The image is somewhat blurry, making it difficult to discern the exact details of the device.

#### RADIO TRANSLUCENCY TEST

| Submitted By: | Jacquin Youngblooc-Johnson<br>JDDE Manufacturing, Inc.<br>446 West 128th Place<br>Chicago, IL | Received: | 06-Mar-08 |
|---------------|-----------------------------------------------------------------------------------------------|-----------|-----------|
| P.O. #: | 401555 | Report #: | 80579 |
| Sample: | Vanguard 4"X4" | | |
| Procedure: | GL7 | | |
| TEMPERATURE: | 19.4 °C | | |
| PRESSURE: | 745.7 mmHg | | |

This uskeratory is aparatited by the Amazon Association for Lesertify Accordition (Albination in Internet dellarmand in annovance will the laboratory's tarms of accracition uness stated othernse in this report.

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r in purchitections of the mass will the directions is the combined uncertainly of the matsurement will a coreinge acco ol 2 195% confidence).

| Sample<br>Number | Thickness<br>(mm) | Transmission | Al eq.<br>(mm) | mm Al eq<br>mm |
|------------------|-------------------|--------------|----------------|----------------|
| ? | 2.76 | 0.884 | 0.39 | 0.142 |

The above data indicato that a single layer of the above samples the radiciranslucancy requirement of 21CFR Ch. 1, J, 1020.30(n) Table 2 (2006) criteria for "Tabletop, movable, 'without articulated joints'' as 'well as Tabletop, with radiolucent particulated foint" 'since it is not greater than 1.7 mm ' Al oquivation

The data also indicates that a single layer does meet the rediotranslucency requirement as a "Tabletop, stationary, "without articulated joints" since it does not exceed ? 2 mm Al equivalent.

| Measurement by | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Annual Property of the<br>1 400 | Brau Ham |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| | | |

Reviewed by
Larry Bryson
Larry G. Bryson, MS-CHS

le: FULL ILLUSTRATION THE

Bryson, MS ale Directo

PH-1-11

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Title: CA L 1 154-4 77 * V TRE F Title:

K & S Associates, Inc. 1926 Elm Tres Drive Nastruitie Tennassea 37270 Tall Frae 800-322-2325 Phone [phone] Fex 815-871-0856

PAGE 1 OF 1

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1

00027002

| | K & S Associates, Inc. | | Test #:<br>Test Date | D080614<br>07-Mar-08 |
|--|------------------------|-------------------------|----------------------|----------------------|
| | | RADIO-TRANSLUCENCY TEST | | |

| Submitted By: | Jacquin Youngblood-Johnson |
|---------------|--------------------------------------------------|
| | JDDB Manufacturing, Inc.<br>446 West 128th Place |
| | Chicago, IL |

| P.O. #: | 401658 |
|------------|-----------|
| Sample: | JPI 6"X6" |
| Procedure: | GL7 |

| | | Received: | 06-Mar-08 |
|--|--|-----------|-----------|
| | | Report #: | 80580 |

| TEMPERATURE: | 19.4 °C |
|--------------|------------|
| PRESSURE: | 745.7 mmHg |

This Laboration in accredited by the American Association (A2LA) and the reasults shown in this report hels them detemined in accordance with the laboratory's torms of accredition unless stated offierwise it. this report.

The indicated sample named on the above date and were assess for their x ray alternation properties under conditions of riserth-រមួយ ព្រះពាទប្រ. The brany of the base characterized in ក្រោះ ចេចកា geomedy using fillers contined as Coloner 102 ki p hati-raine layer = 2.7 mm.Al.Jr.hum. The loaler used to: the measurements has a well understood appoter over e All readings ware carralized to the response of a life. The following table ists an liem number assigned by KBS, the inear blocked a neasured at . S . the fredon of the inzident beam that passed through the thickness of autorials which would alcor equal fraction of the same lo pass finough (A) aquivalence), and thatly, the ratio of Al equivalence is than thickings.

The overal uncertainly of the musertainty is the contined expended uncenturned of the moseument with a coverage factor at 7 (95% contidentia).

| Sample<br>NUMBOR | mm | and and the production of the larges of the course of the comments of the country of the country of the count<br>Thickness Transmission | Al eq.<br>(ITTPT) | min Al ag<br>100.00 | |
|------------------|------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------|--------------------------------------------------------------------------------------------------------------------------|-------------|
| A | 2.63 | 0.888 | 0.30 | The Court of the collection and could by is while to the four and the four and and a form of the Came of Carder<br>0.147 | 1.000:<br>I |

12-1-1-Раде:

The above data indicato that a single layer of the above samples the radiofrance troquirement of 21CFR Ch. 1, J. 1020.30(n) Tablo 2 (2006) criteria for "Tabletop, movable, 'without articulated joints" as well as Tabletop, with radiolucent panel fraving one articulated joint" 'since it is not greater than 1.7 mm ' Al equivalent.

The data also Indicates that a single ine meet the radiotransiacency requirement as a "Tabletop, stationary, "without articulated joints" since it does not exceed 1.2 mm Al equivalent.

| Measurement by | Brad Horn |
|----------------|------------------|
| Title: | CALIBRATION TECH |

| Reviewed by | Larry G. Boyeon, MS, CHP<br>Associate Director |
|-------------|------------------------------------------------|
| Title: | |

K & S Associates, Inc. 1926 Elm Free Drive Nashville, Tennasses 37270 Foll Free 800-522-2325 Phono 615-883-9780 Fax [phone]

PAGE I OF 1

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 2008

Ms. Jacquin C. Youngblood-Johnson President JPI America, Inc. 141 - A Central Avenue FARMINGDALE NY 11735

Re: K081557

Trade/Device Name: Portable Supine Patient Support and Cassette Holder Regulation Number: 21 CFR 892.1850 Regulation Name: Radiographic film cassette Regulatory Class: II Product Code: IXA Dated: May 22, 2008 Received: June 3, 2008

#### Dear Ms. Youngblood-Johnson:

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 (PMA), 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.

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#### Page 2

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.

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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

hope M. Whang

Joyce M. Whang, Ph.D. Acting 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): K081557

Device Name: Portable Supine Patient Support and Cassette Holder

ludications for Usessupine support intended to lay flat on a surface to i hold and position radiographic cassette, also to hold and position patient for radiographic exposure for medical use.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Arge Mht

(Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Reproductive, Abdominal and Radiological Devices K081557

510(k) Number _ http://www.fda.gov/cdrh/ode/indicate.html

8/29/2008