PEF TUBE

K071579 · N.M. Beale Co., Inc. · KNT · Nov 20, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K071579
• Device Name: PEF TUBE
• Applicant: N.M. Beale Co., Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Nov 20, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2

Indications for Use

For use in achieving simultaneous access to the stomach and duodenum to allow fluid sampling in procedures such as pancreatic exocrine function testing.

Device Story

PEF Tube is a soft, dual-lumen gastrointestinal tube featuring a proximal Y-connector for independent access to each lumen. One lumen terminates in the stomach; the second lumen terminates in the duodenum. Used by clinicians to facilitate simultaneous fluid sampling from both locations, primarily for pancreatic exocrine function testing. Device is a passive mechanical accessory; no electronic or software components.

Clinical Evidence

Bench testing only. Performance data consisted of tensile testing to confirm mechanical integrity and safety.

Technological Characteristics

Soft, dual-lumen tube; proximal Y-connector; gastric and duodenal access ports. Mechanical device; no energy source, software, or connectivity.

Indications for Use

Indicated for patients requiring simultaneous access to the stomach and duodenum for fluid sampling, specifically for procedures such as pancreatic exocrine function testing.

Regulatory Classification

Identification

A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).

Special Controls

*Classification.* (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

Predicate Devices

• Bard Dreiling Tube (Unknown)

Submission Summary (Full Text)

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N.M. Beale Company, Inc. PEF Tube

# Section 5 - 510(k) Summary

#### General Information

| Owner's Name: | N.M. Beale Company, Inc. | NOV 2 0 2007 |
|----------------------|------------------------------------------|--------------|
| Address: | 89 Old Shirley Road<br>Harvard, MA 01451 | |
| Telephone Number: | [phone] | |
| Fax Number: | [phone] | |
| Contact Person: | Nathaniel Beale | |
| Subject Device Name: | PEF Tube | |

Trade Name: Common/Usual Name: Product Code: FDA Regulation: Device Classification:

PEF Tube PEF Tube Gastrointestinal tube & accessories KNT - Gastrointestinal tube & accessories 21 CFR 876.5980 - Gastrointestinal tube & accessories Class II

#### Predicate Device Name:

Trade Name: Common/Usual Name: Product Code: FDA Regulation: Device Classification: Premarket Notification: Bard Dreiling Tube Dreiling Tube (Bard Medical, Inc.) Gastrointestinal tube & accessories KNT - Gastrointestinal tube & accessories 21 CFR 876.5980 - Gastrointestinal tube & accessories Class II Unknown

#### Device Description

The PEF Tube consists of a soft, dual-lumen tube with a proximal Y-connector that allows separate access to each of the 2 lumens. One lumen opens distally in the stomach; the second lumen opens into the duodenum.

#### Intended Use

For use in achieving simultaneous access to the stomach and duodenum to allow fluid sampling in procedures such as pancreatic exocrine function testing.

### Performance Testing

Performance data demonstrated that the N.M. Beale Co., Inc. PEF Tube is substantially equivalent to the predicate device and/or met pre-determined acceptance criteria. Performance testing consisted of tensile testing.

#### Conclusion

The PEF Tube meets all the pre-determined acceptance criteria of the testing performed to confirm safety and effectiveness; the PEF Tube is substantially equivalent to the predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

N. M. Beale Company, Inc. c/o Ms. Pamela Papineau, RAC Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue AYER MA 01432

Re: K071579

Trade/Device Name: PEF Tube Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: November 14, 2007 Received: November 16, 2007

Dear Ms. Papineau:

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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting 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.

Nancy C Brogdon

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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K071579

N.M. Beale Company, Inc. PEF Tube

Traditional 510(k) Premarket Notification June 6, 2007

# Section 4 - Indications for Use Statement

510(k) Number (if known):

Device Name: PEF Tube

Indications for Use:

For use in achieving simultaneous access to the stomach and duodenum to allow fluid sampling in procedures such as pancreatic exocrine function testing.

Prescription Use X (Per 21 CFR 801 Subpart D)

했다. 이 대한 노래

OR

Over-the -Counter Use _ (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulda Penner

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number