(165 days)
Unknown
Unknown
No
The description focuses on the physical structure and function of a tube for fluid sampling, with no mention of AI or ML capabilities. Performance testing is limited to tensile strength.
No.
The device is used for fluid sampling for diagnostic purposes (e.g., pancreatic exocrine function testing), not for treating a disease or condition.
No
The device is described as a tube for achieving simultaneous access to the stomach and duodenum to allow fluid sampling. While fluid sampling can be part of diagnostic procedures (like pancreatic exocrine function testing), the device itself is a tool for access and sampling, not for performing the diagnostic analysis or interpreting results. It facilitates the collection of samples, which are then used for diagnosis, but it doesn't perform the diagnosis itself.
No
The device description clearly describes a physical tube with lumens and a connector, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for achieving simultaneous access to the stomach and duodenum for fluid sampling in procedures like pancreatic exocrine function testing. This describes a device used in vivo (within the body) to collect samples, not a device used in vitro (outside the body) to analyze samples.
- Device Description: The description details a tube designed for insertion into the body to access anatomical sites (stomach and duodenum). This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples outside the body, nor does it describe reagents, calibrators, or controls typically associated with IVD devices.
Therefore, the PEF Tube is a medical device used for sample collection in vivo, not an IVD device used for analysis in vitro.
N/A
Intended Use / 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.
Product codes
KNT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
stomach and duodenum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Unknown
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5980 Gastrointestinal tube and accessories.
(a)
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).(b)
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.
0
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 | |
| Harvard, MA 01451 | ||
| Telephone Number: | (978) 456-6990 | |
| Fax Number: | (978) 456-3927 | |
| 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.
1
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.
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 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 (800) 638-2041 or (240) 276-3150 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
3
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