(205 days)
No
The device description and intended use clearly describe a physical, mechanical guide for catheterization. There is no mention of software, algorithms, or data processing that would indicate the presence of AI/ML.
No
The device is an assistive and teaching aide for self-catheterization, not a therapeutic device that directly treats a medical condition.
No
The device is an assistive and teaching tool for self-catheterization, not for diagnosing medical conditions.
No
The device description explicitly states the device consists of a handle and a vaginal insert made of a specific acrylic polymer, indicating it is a physical hardware device.
Based on the provided information, the Asta-Cath™ female catheter guide is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This includes things like blood, urine, tissue, etc., to provide information for diagnosis, monitoring, or screening.
- The Asta-Cath™ is a physical assistive device. Its function is to physically guide a catheter into the urethra. It does not analyze any biological samples or provide diagnostic information.
The intended use and device description clearly indicate that the Asta-Cath™ is a tool for facilitating a medical procedure (catheterization), not for performing diagnostic tests on biological specimens.
N/A
Intended Use / Indications for Use
The Asta-Cath™ female catheter guide is intended for use in the following situations:
- As an assistive device for women who have difficulty performing (i) intermittent self catheterization due to motor or visual disabilities;
- (ii) As a teaching aide for women learning to catheterize themselves for the first time:
- As a teaching aide for caregivers who will be catheterizing women, (iii)
- (iv) As an assistive device and teaching aide for women who are required to perform intermittent self catheterization temporarily following surgery
Product codes
Not Found
Device Description
The Asta-Cath™ 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™ guide inserts into the vagina and spreads the labia to allow for easy access of a catheter into the urethra. When the Asta-Cath™ 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.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5130 Urological catheter and accessories.
(a)
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).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. 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
K961361 P192
12
OCT 31 1996
| Submitter: | A + Medical Products, Inc.
16 Alden Place
Newton, MA 02165
(617) 964-7412 |
|-------------------------------------|-----------------------------------------------------------------------------------------------|
| 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™ 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™ guide inserts into the vagina and spreads the labia to allow for easy access of a catheter into the urethra. When the Asta-Cath™ 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
K16 20
PL012
1 3
510(k) SUMMARY (Cont.)
INDICATIONS FOR USE
The Asta-Cath™ female catheter guide is intended for use in the following situations:
- As an assistive device for women who have difficulty performing (i) intermittent self catheterization due to motor or visual disabilities;
- (ii) As a teaching aide for women learning to catheterize themselves for the first time:
- As a teaching aide for caregivers who will be catheterizing women, (iii)
- (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 The technological characteristics and performance of the Autocath device are identical. 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