(141 days)
970159
Not Found
No
The device description and summary of performance studies focus on the mechanical and functional aspects of a physical medical device (a peritoneal dialysis catheter) and do not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is a Flex-Neck™ Catheter, Infant, used for peritoneal dialysis (PD) therapy. Dialysis is a medical treatment that performs the function of kidneys for patients whose kidneys have failed, thereby treating a health condition.
No
The device is a peritoneal dialysis catheter used for therapy, and its description focuses on its components and implantation, not on diagnosing medical conditions.
No
The device description clearly lists multiple hardware components, including a silicone catheter, stencils, a marking pen, a connector, a cap, and lubricating gel.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being implanted for peritoneal dialysis therapy. This is a therapeutic procedure, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device components are a catheter, stencils, marking pen, connector, cap, and lubricating gel. These are all physical components used for implantation and managing the catheter, not reagents or instruments for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
The device is a medical device used for a therapeutic purpose (peritoneal dialysis), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
If the patient is a suitable candidate for peritoneal dialysis (PD) therapy and is too small for the current Flex-Neck™ catheters, the Flex-Neck™ Catheter, Infant, can be implanted either surgically, peritoneoscopically or percutaneously. The only contraindication to implantation of the Flex-Neck™ PD Catheter, Infant, is if the patient is not a candidate for peritoneal dialysis.
Product codes
78 FJS
Device Description
This device consists of the following components:
1-Flex-Neck™ Catheter, Infant, made of long-term, implantable grade silicone tubing with radiopaque strip and 1 or 2 polyester cuffs. All components are made of the same materials as the Flex-Neck™ Catheter, Adult and Pediatric. The Infant catheter also has 4 rows of side holes punched into the tubing at the distal end to facilitate inflow and outflow of dialysate.
1-Right hand and 1-left hand tunnel marking stencils to mark and guide and thereby assist the implanting doctor to make a sound subcutaneous tunnel for the catheter.
1-Surgical grade marking pen
1-Catheter connector, plastic
1-Catheter cap, plastic
1-Tube (20 cc) of water-soluble lubricating gel
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Infant
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
Functional testing has been performed to demonstrate mechanical integrity and retention.
Key Metrics
Not Found
Predicate Device(s)
970159
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5630 Peritoneal dialysis system and accessories.
(a)
Identification. (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments.
(3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles.
(4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.
(b)
Classification. Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.
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Page 1 of 2
SEP 1 7 2003
SMDA Information 6.
510(k) Summary of Safety and Effectiveness 6.1.
- 6.1.1. Basic Data
| Date Prepared: | April 24, 2003 |
|---|---|
| Company: | MEDIGROUP, Inc. |
| Contact: | John A. Navis, President |
| Phone: | (630) 428-4143 |
| Fax: | (630) 428-4148 |
| E-mail: | jnavis@medigroupinc.com |
6.1.2. Device Information:
Classification Name: Peritoneal Catheter; long-term, indwelling Common Name: Peritoneal Catheter
-
6.1.3. Predicate Device
Flex-NeckTM Peritoneal Catheter, 510 (k) 970159. -
6.1.4. Intended Use & Device Description
- 6.1.4.1. The current Flex-Neck™ catheters (510 (k) 970176) are designed for the typical adult or infant patient who needs peritoneal dialysis (PD) therapy. To facilitate different patient sizes and physiques, there currently are 2 styles (internally coiled and straight) and 5 different adult sizes at 62 cm long and 2 pediatric sizes at 42 cm long. All these catheters share the same outside diameter (OD, 5.1 mm) and the same inside diameter (ID, 3.5 mm). The actual lengths and the location of the polyester cuffs are the primary variables. (See Appendix B.)
The Flex-Neck™ Catheter, Infant (part number CF-4240 and CF-4245) is intended for infants. (The overall length remains at 42 cm, but the OD and ID are smaller -- 3.7 mm and 2.5 mm, respectively. (See Appendix B.)
6.1.4.2. This device consists of the following components:
- 1-Flex-Neck™ Catheter, Infant, made of long-term, a. implantable grade silicone tubing with radiopaque strip and 1 or 2 polyester cuffs. All components are made of the same materials as the Flex-Neck™ Catheter, Adult and Pediatric. The Infant catheter also has 4 rows of side holes punched into the tubing at the distal end to facilitate inflow and outflow of dialysate. (See Appendix B for additional details.)
1
031351
Page 2 of 2
- b. 1-Right hand and 1-left hand tunnel marking stencils to mark and guide and thereby assist the implanting doctor to make a sound subcutaneous tunnel for the catheter.
- 1-Surgical grade marking pen C.
- 1-Catheter connector, plastic d.
- e. 1-Catheter cap, plastic
- 1-Tube (20 cc) of water-soluble lubricating gel f.
6.1.5. Testing
Functional testing has been performed to demonstrate mechanical integrity and retention.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like shapes. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
SEP 1 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John A. Navis President MEDIGROUP, Inc. 505 Weston Ridge Drive NAPERVILLE IL 60563-3932
Re: K031351
Trade/Device Name: Flex-Neck™ PD Catheter, Infant; Part #CF-4240 and CF-4245 Regulation Number: 21 CFR §876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: 78 FJS Dated: June 23, 2003 Received: June 24, 2003
Dear Mr. Navis:
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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
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
4
KO 31357
7. Indications for Usc
510(k) Number:
Device Name:
Flex-Neck™ PD Catheter, Infant
If the patient is a suitable candidate for peritoneal dialysis (PD) therapy and is too small for the current Flex-Neck™ catheters, the Flex-Neck™ Catheter, Infant, can be implanted either surgically, peritoneoscopically or percutaneously. The only contraindication to implantation of the Flex-Neck™ PD Catheter, Infant, is if the patient is not a candidate for peritoneal dialysis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use V OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) (Optional Format 1-2-96)
David R. Flynn
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number.