ASTA-CATH

K961361 · A+ Products · GBM · Oct 31, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K961361
• Device Name: ASTA-CATH
• Applicant: A+ Products
• Product Code: GBM · Gastroenterology, Urology
• Decision Date: Oct 31, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Indications for Use

The Asta-Cath™ female catheter guide is intended for use in the following situations: (i) As an assistive device for women who have difficulty performing intermittent self catheterization due to motor or visual disabilities; (ii) As a teaching aide for women learning to catheterize themselves for the first time; (iii) As a teaching aide for caregivers who will be catheterizing women; (iv) As an assistive device and teaching aide for women who are required to perform intermittent self catheterization temporarily following surgery.

Device Story

Asta-Cath™ female catheter guide; assists/teaches intermittent self-catheterization. Device features handle with three alignment holes and vaginal insert. Operation: insert into vagina to spread labia; alignment holes guide catheter into urinary meatus. Used by women or caregivers in home/clinical settings. Facilitates catheter access; improves ease of use for patients with motor/visual impairments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Perspex® GHI Acrylic Polymer CP-927 GHF. Form factor: Handle with three alignment holes and vaginal insert. Non-powered, manual device.

Indications for Use

Indicated for women requiring intermittent self-catheterization, including those with motor or visual disabilities, those learning self-catheterization, those requiring temporary post-surgical catheterization, and caregivers assisting with female catheterization.

Regulatory Classification

Identification

A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

Predicate Devices

• Autocath Set (K910876)

Submission Summary (Full Text)

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K961361 P192

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OCT 31 1996

# 510(k) SUMMARY

| **Submitter:** | A* Medical Products, Inc.
16 Alden Place
Newton, MA 02165
[phone] |
| --- | --- |
| **Contact Person:** | Linda R. Asta, President |
| **Device Name:** | Asta-Cath^{TM} Guide
Female Self Catheter Guide |
| **Classification Name:** | Urinary Catheter Accessory |
| **Legally Marketed Equivalent Device:** | Autocath Set, 510(k) number K910876 |

## DESCRIPTION OF DEVICE

The Asta-Cath^TM is a female catheter guide designed to teach and/or assist women or their caretakers in performing self-catheterization. The Device consists of a handle which has three alignment holes and a vaginal insert. It is made of the Perspex^® GHI Acrylic Polymer CP-927 GHF.

The Asta-Cath^TM guide inserts into the vagina and spreads the labia to allow for easy access of a catheter into the urethra. When the Asta-Cath^TM guide is in place, one of the three alignment holes will align with the urinary meatus, thus allowing easy access of a catheter into the urethra.

{1}

K910876
? 2 of 2

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## 510(k) SUMMARY (Cont.)

### INDICATIONS FOR USE

The Asta-Cath™ female catheter guide is intended for use in the following situations:

(i) As an assistive device for women who have difficulty performing intermittent self catheterization due to motor or visual disabilities;

(ii) As a teaching aide for women learning to catheterize themselves for the first time;

(iii) As a teaching aide for caregivers who will be catheterizing women;

(iv) As an assistive device and teaching aide for women who are required to perform intermittent self catheterization temporarily following surgery.

### TECHNOLOGICAL INFORMATION

The Asta-Cath™ female catheter guide is substantially equivalent to the Autocath Set, 510(k) number K910876. The indications for use for the Asta-Cath™ guide and the Autocath Set are identical. The technological characteristics and performance of the Autocath device are substantially similar to those of the Asta-Cath™ guide. The placement of the alignment holes on the Asta-Cath™ guide differ from that of the Autocath device in that the holes are located on the handle portion of the device rather than the vaginal insert portion. This minor technological difference improves the effectiveness of the Asta-Cath™ guide and does not interfere with its safety and performance.