(239 days)
Prescription: Suntouch Topical Hemostatic Dressing is indicated for the management of topical wounds and to temporary control of external surface bleeding.
Over the Counter: Suntouch Topical Hemostatic Dressing is indicated for temporary external topical bleeding of minor cuts, minor lacerations, and it is contraindicated for internal use.
The Suntouch Topical Hemostatic Dressing is made from regenerated cotton cellulose, chemically treated to become water-soluble. When contacting blood and exudates, they expand into clear gel, thereby adhering and creating pressure to seal the wound. The gauzes are sold in the following forms: Sheet, rolls, and pack (four layers).
Here's an analysis of the acceptance criteria and the study proving the device meets those criteria, based on the provided text, specifically regarding the "Suntouch Topical Hemostatic Dressing":
This document outlines a 510(k) submission, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive clinical trials. Therefore, the "study" described largely involves comparative performance testing against the predicate device and adherence to recognized standards.
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly defines acceptance criteria by comparing the performance of the "Suntouch Topical Hemostatic Dressing" to known performance metrics of a predicate device (Bloodstop Hemostatic Gauze, K072681/K071578). The key criteria relate to hemostatic performance and biocompatibility.
| Acceptance Criteria (Implied) | Suntouch Topical Hemostatic Dressing Reported Performance | Predicate Device Performance (K072681/K071578) |
|---|---|---|
| Hemostatic Performance: | ||
| Average Stop Bleeding Time on Swine Neck Artery Wound: | 55.0 minutes (vs. 108.75 min for control dressing) | 65.0 minutes (vs. 108.75 min for control dressing) - claimed same as Predicate Device 2 |
| Average Blood Loss on Swine Neck Artery Wound: | 82.6 grams (vs. 163.84 g for control dressing) | 81.9 grams (vs. 163.84 g for control dressing) - claimed same as Predicate Device 2 |
| In Vitro Procoagulant Test (Blood Clotting Ability): | Test Group Clog in 34 seconds, Blank Control Group Does not Clog | Not tested (No similar data available for predicate device for this test) |
| Biocompatibility: | ||
| Cytotoxicity (ISO 10993-5): | No Toxic Effect | Biocompatible (General claim for predicate) |
| Skin Irritation and Sensitization (ISO 10993-10): | No Effect | Biocompatible (General claim for predicate) |
| Systemic Toxicity (ISO 10993-11): | No Effect | Biocompatible (General claim for predicate) |
| Pyrogenicity (ISO 10993-11): | No Effect | Biocompatible (General claim for predicate) |
| Chemical Structure: | Almost identical Infrared spectra to predicate | (Used as a baseline for comparison) |
| Sterilization: | Validated following ISO 11137-2: 2006 | (Implicitly also sterilized as medical devices) |
| Mechanism of Action: | Expands into clear gel upon contact with blood/exudates, adhering and creating pressure to seal the wound. | Same as predicate (Expands into clear gel, adhering and creating pressure to seal the wound). |
| Material: | Regenerated cotton cellulose, oxidized and etherized to be water-soluble. | Same (Identical Infrared Spectrum), oxidized and etherized to be water-soluble. |
| Indications for Use: (Prescription & Over-the-Counter similar) | For management of topical wounds, temporary control of external surface bleeding, minor cuts/lacerations. | Similar indications for use in predicate devices. |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Hemostatic Performance Test (Swine Neck Artery Wound): The sample size is not explicitly stated in the provided text. It mentions "Stop bleeding tests were conducted on swine neck artery wound."
- In Vitro Procoagulant Test: Sample size not explicitly stated.
- Biocompatibility Tests: Sample size not explicitly stated for individual tests (Cytotoxicity, Skin Irritation, Systemic Toxicity, Pyrogenicity).
- Data Provenance: The hemostatic performance tests and biocompatibility tests appear to be prospective experiments conducted specifically for this submission. The origin of the data is implied to be from the manufacturer's testing facility or a contracted lab. The document does not specify a country of origin for the test data itself, beyond the manufacturer being in China.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This type of information is generally not required or provided in a 510(k) submission that relies on bench testing and comparison to predicates for performance. The "ground truth" for these tests (e.g., actual bleeding time, blood loss, presence of toxic effects) is established by the standardized protocols of the tests themselves, rather than expert consensus on individual cases. The tests are objective measurements.
4. Adjudication Method for the Test Set:
Not applicable. The tests performed are objective, quantitative measurements (e.g., time, mass, presence/absence of an effect), not subjective assessments requiring adjudication by human readers/experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or clinical assessments where human interpretation plays a significant role. This submission focuses on a physical device for wound care with objective performance measures.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Study was done:
Yes, a standalone performance assessment was done for the device regarding its hemostatic and biocompatibility characteristics. The device's performance was evaluated independently against control dressings (for hemostasis) and against established standards (for biocompatibility). This is essentially an "algorithm only" equivalent, as it's the device's inherent property being measured, not its interaction with a human operator.
7. Type of Ground Truth Used:
- Hemostatic Performance: Objective measurements of physiological outcomes (stop bleeding time, blood loss) on an animal model (swine neck artery wound). The "control dressing" served as a baseline.
- In Vitro Procoagulant Test: Objective measurement of physiological outcome (blood clotting time) in an in-vitro setting.
- Biocompatibility: Established by adherence to international consensus standards (ISO 10993 series), which define acceptable biological responses. The ground truth here is the fulfillment of these predefined biological safety criteria.
- Chemical Structure: Established by analytical chemistry techniques (Infrared Spectroscopy), where an "identical" spectrum to a predicate device serves as confirmation of the basic chemical structure.
8. Sample Size for the Training Set:
This concept is not directly applicable to this type of device submission. The "training set" is a term typically used in machine learning or AI algorithm development. For a physical medical device, there isn't a "training set" in the same sense. The development of the device itself involves iterative design and testing, but not a formally defined "training set" from which an algorithm "learns."
9. How the Ground Truth for the Training Set was Established:
As mentioned above, the concept of a formal "training set" with established ground truth is not relevant here. The development process for a physical device involves R&D, material science, engineering, and iterative testing, where "ground truth" for design decisions comes from scientific principles, material properties, and preliminary testing, not from a labeled dataset.
N/A