(205 days)
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
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.
This submission describes a medical device, the Asta-Cath™ Guide, and relies on substantial equivalence to a predicate device (Autocath Set, K910876) rather than presenting new clinical study data with acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and performance studies is not directly available in the provided text.
Here is an analysis based on the provided text, addressing the points where information is available and indicating where it is not:
1. Table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as this is a substantial equivalence submission, not a de novo or PMA submission with specific performance endpoints. The "acceptance criteria" here are inherently tied to demonstrating substantial equivalence to the predicate device in terms of safety and effectiveness.
- Reported Device Performance: The submission claims that the Asta-Cath™ Guide's "technological characteristics and performance... are substantially similar" to the predicate device. It also states that the design improvement (location of alignment holes) "improves the effectiveness of the Asta-Cath™ guide and does not interfere with its safety and performance." No quantitative performance metrics are provided.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Autocath Set, K910876) in terms of safety and effectiveness. | "Technological characteristics and performance of the Autocath device are substantially similar to those of the Asta-Cath™ guide." |
| Design modification (alignment hole placement) improves effectiveness without compromising safety or performance. | "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." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. The submission does not describe a clinical study with a test set of data for the Asta-Cath™ Guide itself. It relies on the existing market history and assumed safety/effectiveness of the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a medical device for self-catheterization assistance, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No new ground truth data was generated for this 510(k) submission as it relies on substantial equivalence. The "ground truth" for the predicate likely came from its own clearance process, which isn't detailed here.
8. The sample size for the training set
- Not applicable. This submission does not describe a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set is described.
Summary of available information from the provided text:
The information provided describes a 510(k) submission for the Asta-Cath™ Guide, a female self-catheter guide. The submission seeks clearance through substantial equivalence to a predicate device, the Autocath Set (K910876). The core of the argument is that the Asta-Cath™ Guide has "substantially similar" technological characteristics and performance to the predicate, with a minor design difference (placement of alignment holes) that is claimed to "improve[] the effectiveness... and does not interfere with its safety and performance."
Crucially, the provided document does not detail any new clinical or performance studies with acceptance criteria, test sets, expert ground truth, or statistical analyses specific to the Asta-Cath™ Guide. Such information would typically be found in submissions for novel devices or those requiring de novo classification or premarket approval (PMA), rather than a substantial equivalence (510(k)) pathway. The FDA's 510(k) process primarily evaluates whether a new device is "as safe and effective as" a legally marketed predicate device.
§ 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.