SPECBOARD JR.

K123414 · Macbrud Corp., Medical Division · IZH · Jan 11, 2013 · Radiology

Device Facts

• Record ID: K123414
• Device Name: SPECBOARD JR.
• Applicant: Macbrud Corp., Medical Division
• Product Code: IZH · Radiology
• Decision Date: Jan 11, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1710
• Device Class: Class 2

Indications for Use

SPECBOARD JR is intended to be used as an accessory to a mammographic x-ray system. The SPECBOARD JR is used to contain the mammographic specimen from the patient when transported to the x-ray device and then accompany the x-ray image to the pathology laboratory.

Device Story

SPECBOARD JR is a specimen transport and identification device used in operating rooms. It consists of a foam core base, a tape hinge, a cardboard cover, and a Velcro latch. The base features absorbent blotter paper and two radio-opaque nickel stencils (alpha and numerical). During surgery, a breast specimen is placed on the blotter; the cover is closed and secured. The device is then placed in a mammographic x-ray system. The resulting x-ray image displays the specimen alongside the radio-opaque stencils, providing the pathologist with a spatial reference for lesion localization and tissue sampling. The device facilitates specimen handling and orientation from the OR to the pathology lab.

Clinical Evidence

No clinical data. The device is a mechanical accessory; substantial equivalence is based on design, material, and functional similarity to the predicate device.

Technological Characteristics

Materials: foam core, cardboard, tape, Velcro, nickel stencils. Dimensions: smaller form factor than predicate. Energy source: none (passive accessory). Connectivity: none. Sterilization: not specified. Sensing: radio-opaque stencils for x-ray visualization.

Indications for Use

Indicated for use as an accessory to mammographic x-ray systems to contain and transport breast tissue specimens from patients undergoing surgical excision to x-ray imaging and pathology laboratories.

Regulatory Classification

Identification

A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• SPECBOARD (K891090)

Submission Summary (Full Text)

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## 510(k) Summary

This is a 510(k) filing for a new product, the SPECBOARD JR. K123414 The SPECBOARD JR product is substantially equivalent to the SPECBOARD product (510(k) K891090, decision 04/07/1989), the difference being in size. The SPECBOARD JR is smaller than the SPECBOARD.

- 1. Submission Date: October/31/2012
- 2. Submitter Name: MacBrud Corporation, Submitter Address: 14021 SW 143 Court, Unit 6, Miami, Florida 33186, Submitter Phone: [phone], Submitter FAX: [phone]
- Establishment Registration Number: 1052243 3.
- Common Name of Device: Specimen Transport and Identification 4.
- Trade Name & Model Number: SPECBOARD JR model 222 5.
- Classification Name and Class: System, X-Ray, Mammographic, IZH 6.
- Regulation Number: 892.1710 7.
- 8. Reason for the 510(k) – New Device. The SPECBOARD JR product is substantially equivalent to the SPECBOARD product (510(k) K891090, decision 04/07/1989), the difference being in size. The SPECBOARD JR is smaller than the SPECBOARD. Newer X-ray devise used in the operating room are more compact and require less energy than previous x-ray machines. The SPECBOARD JR uses the same design elements and packages them into a smaller package to allow for the use in these newer smaller portable x-ray machines.
- 9. Identification of Substantially Equivalent Product: SPECBOARD (510(k) K891090, decision 04/07/1989
- 10. The SPECBOARD is a medical device that allows for accurate localization of suspect lesions in breast tissue. The SPECBOARD JR is comprised of a foam core base coupled with a tape hinge along one edge to a thick cardboard cover. On the base foam core piece there is a centrally located piece of absorbent blotter paper. Along two joining edges of the blotter are two radio-opaque nickel stencils, one marked with alpha characters and the other with numerical characters. The SPECBOARD JR is used in the operating room where the surgeon will remove a suspect portion of the breast tissue and place it on the blotter portion of the SPECBOARD JR. The cover is then closed, sandwiching the breast specimen between the cover and the base. The cover is then secured with the Velcro latch and an x-ray is taken of the specimen inside the SPECBOARD JR. The resulting x-ray image will show the perpendicular stencils along the border of the blotter paper and the specimen on the blotter paper. Any lesions will show up within the specimen and the pathologist then has a reference of where to cut into the specimen to withdrawal a piece for analysis. The SPECBOARD predicate product has been in worldwide use since 1989 and is a couple of inches larger than the SPECBOARD JR. The same materials are used in both products. The SPECBOARD JR is expected to have the same safety record as the predicate SPECBOARD product, no failures reports.
- 11. Indications for Use: SPECBOARD JR is intended to be used as an accessory to a mammographic x-ray system. The SPECBOARD JR is used to contain the mammographic specimen from the patient when transported to the x-ray device and then accompany the x-ray image to the pathology laboratory.

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### Decision Summary for Web Posting

#### Decision Summary, K123414

This 510(k) was reviewed under OIR's Pilot Triage Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant's 510(k) summary for a summary of the information that supports this SE determination.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

January 11, 2013

Mr. Todd Lary President MacBrud Corporation - Medical Division 14021 SW 143 Court, Unit 6 MIAMI FL 33186

Re: K123414

Trade/Device Name: SPECBOARD JR Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: II Product Code: IZH Dated: November 1, 2012 Received: December 20, 2012

Dear Mr. Lary:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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#### Page 2-Mr. Lary

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Sean M. Boyd -S for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K123414

Device name: SPECBOARD JR

Indications for Use: SPECBOARD JR is intended to be used as an accessory to a mammographic x-ray system. The SPECBOARD JR is used to contain the mammographic specimen from the patient when transported to the x-ray device and then accompany the x-ray image to the pathology laboratory.

Prescription Use X (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 In Vitro Diagnostics and Radiological Health (OIR)

# Sean My Boyd -S

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) K123414

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