(90 days)
510(k)883303A, 510(k)991042
Not Found
No
The summary describes a simple mechanical device (stainless steel tube) used for implanting a catheter and makes no mention of AI, ML, image processing, or any data-driven algorithms.
No
The device is described as an instrument used to implant a catheter, not a device that directly provides therapy itself.
No
The device is described as an implantation tool for a catheter, not for diagnosing conditions.
No
The device description explicitly states it is a "Stainless steel, quasi tubular (U shape) device," indicating it is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "implant the Ash Advantage™ catheter." This describes a surgical or procedural tool used in vivo (within the body) to facilitate the placement of another medical device.
- Device Description: The description of a "Stainless steel, quasi tubular (U shape) device" is consistent with a surgical instrument, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely procedural – assisting in the implantation of a catheter.
N/A
Intended Use / Indications for Use
The Key Tube is designed to be used to implant the Ash Advantage™ catheter. No usage change from original Ash Advantage catheter 510(k) 991042.
Product codes (comma separated list FDA assigned to the subject device)
78 FJS
Device Description
Stainless steel, quasi tubular (U shape) device, approximately 200 mm long and 8.0 mm diameter.
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
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)
Ash Advantage™ catheter clinical trials were conducted in three dialysis centers. A total of fourteen catheters were implanted in thirteen patients via the peritoneoscopic or laprascopic method (doctor's choice). All implanting doctors used the prototype version of the Key Tube™ to implant the Ash Advantage™ catheter. Clinical results were that all catheters were successfully implanted; the Key Tube™ functioned as designed. That is, the T junction of the Ash Advantage™ was against the parietal peritoneum; the distal cuff was within the rectus sheath; incision of the rectus sheath was avoided.
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.
510(k)883303A, 510(k)991042
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
§ 876.5630 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.
0
KO13017
Page 10f1
DEC 0 6 2001
7.1. 510(k) Summary of Safety and Effectiveness
7.1.1 Basic Data
| Date Prepared: | September 6, 2001 |
|---|---|
| Company: | MEDIGROUP, Inc |
| Contact: | John A. Navis, President |
| Phone: | (630) 428-4143 |
| Fax: | (630) 428-4148 |
| E-mail: | jnavis@medigroupinc.com |
7.1.2 Device Information:
Classification Name: Common Name:
Peritoneal Catheter Accessory Catheter Implantation Device
7.1.3 Predicate Device
This device (Key Tube™) is an adaptation (not replacement) for an existing tool, Cuff Implantor®, currently produced by Medigroup and included in two of its Y-TEC® kits, VP-112 and VP-210, 510(k)883303A and adapted in April 7, 1993 letter to FDA. An early prototype Key Tube version was designed and used during the Ash Advantage™ clinical trials [510(k)991042].
-
Ash Advantage™ catheter clinical trials were conducted in three dialysis centers. 7.1.4 A total of fourteen catheters were implanted in thirteen patients via the peritoneoscopic or laprascopic method (doctor's choice). All implanting doctors used the prototype version of the Key Tube™ to implant the Ash Advantage™ catheter.
Clinical results were that all catheters were successfully implanted; the Key Tube™ functioned as designed. That is, the T junction of the Ash Advantage™ was against the parietal peritoneum; the distal cuff was within the rectus sheath; incision of the rectus sheath was avoided. -
7.1.5 Device Description and Intended Use
Stainless steel, quasi tubular (U shape) device, approximately 200 mm long and 8.0 mm diameter.
It is designed to be used to implant the Ash Advantage catheter.
1
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that converge and then separate into wavy lines at the bottom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 6 2001
Mr. John A. Navis President Medigroup, Inc. 505 Weston Ridge Drive NAPERVILLE IL 60563-3932 Re: K013017 Trade/Device Name: Key Tube™ (KT-2580) Regulation Number: 21 CFR §876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: 78 FJS Dated: September 6, 2001
Received: September 7, 2001
Dear Mr. Navis:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(t) premexice is substantially equivalent (for the indications ferenced above and nave determined ly marketed predicate devices marketed in interstate 101 use stated in the cholosure) to regars actment date of the Medical Device Amendments, or to conmente province to May 20, 1978, the enaounce with the provisions of the Federal Food, Drug, devices mat have been reculted in avee approval of a premarket approval application (PMA). alla Cosment Act (Act) that do not require appro the general controls provisions of the Act. The 1 ou may, diciolor, manov of the Act include requirements for annual registration, listing of general controls provisions of the rice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), II your device is classified (300 above) and 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 I lease be advised that I Dri 3 issualite of our device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any I coord statutes and roguirements, including, but not limited to: registration and listing Compry with an the Act 3 requirements, models. good manufacturing practice requirements as set manie (21 OF IC Part 801), faceming (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality bystems (sections 531-542 of the Act); 21 CFR 1000-1050.
2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed notification. The PDA midmis of successification 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 811), please II you desire specific advice for your de rest of ollowing numbers, based on the regulation number at the top of this 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 Additionally, for questions on and prosses of the regulation entitled, "Misbranding Office of Comphanee at (301) 39 ( 1057) Part 807.97). Other general information on by reletence to premarket notification (2) obtained from the Division of Small Manufacturers, your responsibilities the Act Her May of other of other (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
3
510(k) Number:
Device Name:
Medigroup Key Tube™
Indications for Use:
The Key Tube is designed to be used to implant the Ash Advantage™ catheter. No usage change from original Ash Advantage catheter 510(k) 991042.
(PLEASE DO NOT WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
David le. Segerson
Division of Ophthalmic, Anesthesia,
and Neurological Devices
510(k) Number K013017