(25 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and established performance of the drains, with no mention of AI or ML.
Yes
The device is used for the drainage of urine, which is a therapeutic intervention aimed at managing a patient's medical condition.
No
Explanation: The device is described as a drain for urine, which is a therapeutic function. There is no mention of it being used to gather information for diagnosis.
No
The device description clearly states it is a physical catheter made of natural rubber latex with a shaft, funnel, and various distal end configurations. It is a hardware device for drainage.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. They are used outside of the body (in vitro).
- Device description: The description clearly states that the Bard malecot and pezzer drains are catheters inserted into the patient (suprapubically into the bladder or through a nephrostomy tract) for the purpose of draining urine. This is an in vivo (within the body) function.
- Intended Use: The intended use is "drainage of urine," which is a therapeutic or management function, not a diagnostic test performed on a specimen.
Therefore, based on the provided information, this device is a medical device used for drainage within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Bard malecot and pezzer drains are intended for use in the drainage of urine. The drains are inserted suprapubically into the bladder or through a nephrostomy tract.
Product codes (comma separated list FDA assigned to the subject device)
FEW
Device Description
The drains are composed of a straight or angled, single lumen catheter shaft. The proximal end, which remains external to the patient, is a funnel for connection to a urine collection device. The funnel is printed with a product code, date code, product type and French size, The distal end, which is placed in the patient, is offered in various configurations including whistle tip, 2-wing, 4-wing, retention head with drainage eyes or open end retention head. The entire drain is composed of natural rubber latex.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder, nephrostomy tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
The Bard malecot and pezzer drains referenced in this submission are held to the same design, manufacture, and performance specifications as those catheters currently manufactured by Bard. The appropriate design verification and validation activities for the modifications to the device were conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.5090 Suprapubic urological catheter and accessories.
(a)
Identification. A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.(b)
Classification. (1) Class II (performance standards).(2) Class I for the catheter punch instrument, nondisposable cannula and trocar, and gastro-urological trocar. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Ko70879
APR 2 4 2007
Bard Urological Division C. R. Bard, Inc. 13183 Harland Dr. Covington, GA 30014
Image /page/0/Picture/3 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a distinct and modern appearance. The font style is consistent throughout the word, creating a unified and recognizable logo or brand name.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMA
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
- A. Submitter's Information:
Submitter's Name: Address:
Contact Person: Contact Person's Phone: Contact Person's Fax:
C. R. Bard, Inc., Urological Division 13183 Harland Dr. Covington, Georgia 30014 John Knorpp (678) 342-4920 (770) 788-5513
-
B. Device Name:
Trade Name(s): Bard malecot and pezzer drains Common/Usual Name: Malecot and pezzer drains Classification Names: 78 FEW - (Catheter, Malecot) CFR Reference: 21 CFR 876.5090 -
C. Predicate Device Name:
Trade Name(s):
Bard malecot and pezzer drains (K910197 and K910846)
-
D. Device Description:
The drains are composed of a straight or angled, single lumen catheter shaft. The proximal end, which remains external to the patient, is a funnel for connection to a urine collection device. The funnel is printed with a product code, date code, product type and French size, The distal end, which is placed in the patient, is offered in various configurations including whistle tip, 2-wing, 4-wing, retention head with drainage eyes or open end retention head. The entire drain is composed of natural rubber latex. -
E. Intended Use:
Bard malecot and pezzer drains are intended for use in the drainage of urine. The drains are inserted suprapubically into the bladder or through a nephrostomy tract. -
F. Technological Characteristics Summary:
The modified device has the same intended use, general design and fundamental scientific technology as the predicate device. -
G. Performance Data Summary:
The Bard malecot and pezzer drains referenced in this submission are held to the same design, manufacture, and performance specifications as those catheters currently manufactured by Bard. The appropriate design verification and validation activities for the modifications to the device were conducted.
1
Image /page/1/Picture/0 description: The image shows a logo with the text "DEPARTMENT OF HEALTH & HUMAN" arranged in a circular fashion around a stylized graphic. The graphic consists of three abstract, curved lines that resemble human profiles facing to the right. The logo is black and white and appears to be a scanned image.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 2 4 2007
John C. Knorpp, RAC Manager, Regulatory Affairs Bard Urological Division C. R. Bard, Inc. 13183 Harland Drive COVINGTON GA 30014
K070879 Re:
Trade/Device Name: Bard Malecot and Pezzer Drains Regulation Number: 21 CFR §876.5090 Regulation Name: Suprapubic urological catheter and accessories Regulatory Class: II Product Code: FEW Dated: March 27, 2007 Received: March 30, 2007
Dear Mr. Knorpp:
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, controls provisions of the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registrations, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your may publish further conserved Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/1/Picture/10 description: The image shows a circular logo with the letters "FDA" in large, bold font in the center. Above the letters, the years "1906-2006" are printed, indicating a centennial celebration. Below the letters, the word "Centennial" is written in a cursive font, and three stars are aligned beneath it. The logo is surrounded by a dotted border, giving it a seal-like appearance.
Promoting and Promoting Public Health
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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-011 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-011 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-012 |
| Other | 240-276-010 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 (301) 443-6597 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
Bard Urological Division, C.R. Bard, Inc. Malecot and Pezzer Drains Premarket Notification [510(k)]
1.3 Indications for Use Statement
510(k) Number (if known): K070879
Device Name: ____Bard Malecot and Pezzer Drains
Indications for Use:
· Bard malecot and pezzer drains are intended for use in the drainage of urine. The drains are inserted suprapubically into the bladder or through a nephrostomy tract.
X Prescription Use _ (Part 21 CFR 801 Subpart D) ANDYOR
Over-The-Counter Use (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)
Raman Choodon
(Division Sign-Off)
Division of Reproductive, A dominal and Radiological Devices
510(k) Number K070879
(Recommended Format 11/13/2003)