(130 days)
XSTAT 30 is a hemostatic device for the control of severe, life-threatening bleeding from junctional wounds in the groin or axilla not amenable to tourniquet application in adults and adolescents.
XSTAT 30 is a hemostatic device for the control of severe, life-threatening bleeding from narrow entrance extremity wounds in the arms or legs in adults and adolescents.
XSTAT 30 is a temporary device for use up to four (4) hours until surgical care is acquired. It should only be used for patients at high risk for immediate life-threatening bleeding from, hemodynamically significant (Advanced Trauma Life Support class 3 or 4 hemorrhagic shock), non-compressible junctional wounds or narrow entrance extremity wounds, and when definitive care at an emergency care facility cannot be achieved within minutes.
XSTAT 30 is NOT indicated for use in: the thorax; the pleural cavity; the mediastinum; the retroperitoneal space; the sacral space; tissues above the inguinal ligament; or tissues above the clavicle.
The XSTAT 30 device consists of an applicator and plunger that facilitates delivery of minisponges to external bleeding wounds. Upon contact with blood, the minisponges absorb blood and, if unencumbered, can expand to a pre-compressed height of 40-50 mm within approximately 20 seconds.
The applicator is a cylindrical body comprised of injection molded, medical grade polypropylene with an attached medical grade, phthalate-free PVC tip and an attached low density polyethylene (LDPE) end cap. The plunger is comprised of injection molded, 20% glass-filled polycarbonate and is used to deplov the minisponges from the applicator. One (1) applicator filled with ~ 108 minisponges and packaged with one (1) plunger in a vacuum-sealed nylon/poly pouch and terminally sterilized by gamma radiation to a sterility assurance level of 106. The XSTAT 30 device consists of vacuumsealed, gamma radiated, inner pouch, packaged inside a larger outer pouch as a one (1) pack configuration. Each outer pouch also contains one (1) casualty card and one (1) package insert. The Indications for Use, Instructions for Use (IFU) and UDI labels are affixed to the outer pouch, along with a UDI label on the inner pouch.
This document is a 510(k) Summary for the XSTAT 30 device, a hemostatic device. The purpose of a 510(k) is to demonstrate that a device is substantially equivalent to a legally marketed predicate device. This submission does not contain acceptance criteria or a study proving the device meets acceptance criteria in the way this request is typically interpreted for AI/ML devices, or even for many traditional medical devices.
Instead, the document details a comparison of the new XSTAT 30 (K180051) to its predicate devices (XSTAT 30 and XSTAT 12, K170334). The "acceptance criteria" here are essentially that the new device performs similarly to or better than the predicate device across various performance and safety metrics, and that any differences do not raise new questions of safety or effectiveness.
Here's a breakdown based on your request, as best as the provided text allows:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission, the "acceptance criteria" are implied by the performance of the predicate device, and the "reported device performance" is the demonstration that the new device meets or exceeds those. The document states:
"The XSTAT 30 device is substantially equivalent to the predicate devices. The XSTAT 30 has the same intended use and indications for use, same principles of operation and similar technological characteristics. The Substantial Equivalence Summary tables below details and compares the XSTAT 30 to the predicate XSTAT devices."
The table provided directly compares the characteristics of the "New: XSTAT 30" and "Predicate: XSTAT 30 and XSTAT 12 (K170334)". In all categories, the specifications for the new device are either identical or shown to be an acceptable variation (e.g., slightly different dimensions/weight for a one-pack vs. a three-pack configuration, with similar underlying technology).
Therefore, the acceptance criteria are implicitly that the new XSTAT 30 performs equivalently in these areas, and the reported device performance is that it does.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (New XSTAT 30) |
|---|---|---|
| Intended Use | Control of bleeding from wounds in the groin or axilla not amenable to tourniquet application and narrow entrance extremity wounds in the arms or legs in adults and adolescents. | XSTAT 30 is intended for the control of bleeding from wounds in the groin or axilla that are not amenable to tourniquet application and narrow entrance extremity wounds in the arms or legs in adults and adolescents. (Identical) |
| Indications for Use | Hemostatic device for the control of severe, life-threatening bleeding from junctional wounds in the groin or axilla not amenable to tourniquet application or narrow entrance extremity wounds in the arms or legs in adults and adolescents; temporary device for use up to 4 hours; only for high-risk patients with hemodynamically significant, non-compressible wounds when definitive care cannot be achieved within minutes. Exclusions: thorax, pleural cavity, mediastinum, retroperitoneal space, sacral space, above inguinal ligament, above clavicle. | (Identical to Predicate) XSTAT 30 is a hemostatic device for the control of severe, life-threatening bleeding from junctional wounds in the groin or axilla not amenable to tourniquet application in adults and adolescents. |
| XSTAT 30 is a hemostatic device for the control of severe, life-threatening bleeding from extremity wounds in the arms or legs in adults and adolescents. | ||
| XSTAT 30 is a temporary device for use up to four (4) hours until surgical care is acquired. It should only be used for patients at high risk for immediate life-threatening bleeding from, hemodynamically significant (Advanced Trauma Life Support class 3 or 4 hemorrhagic shock), non-compressible junctional wounds or narrow entrance extremity wounds, and when definitive care at an emergency care facility cannot be achieved within minutes. | ||
| XSTAT 30 is NOT indicated for use in: the thorax; the pleural cavity; the mediastinum; the abdomen; the retroperitoneal space, the sacral space; tissues above the inguinal ligament; or tissues above the clavicle. | ||
| User Population | Civilian and battlefield patients, Adults and Adolescents. | Civilian and battlefield patients, Adults and Adolescents. (Identical) |
| Technological Characteristics | Minisponges, Applicator, Casualty Card, Packaging. | Minisponges, Applicator, Casualty Card, Packaging. (Identical) |
| Dimensions (l x w x h) | 3-Pack: 254mm x 165mm x 38mm; 1-Pack: 254mm x 165mm x 38mm | 1-Pack: 295mm x 180mm x 35mm (Slight dimensional difference for a 1-pack, not raising new safety/effectiveness) |
| Weight | 3-Pack: 0.25kg; 1-Pack: 0.1kg | 1-Pack: 0.11kg (Slight weight difference for a 1-pack, not raising new safety/effectiveness) |
| Safety Features | Radiopaque marker laminated to sponge with medical grade low-density polyethylene film. | Radiopaque marker laminated to sponge with medical grade low-density polyethylene film. (Identical) |
| Biocompatibility | Cytotoxicity (ISO 10993-5); Sensitization (ISO 10993-10); Irritation (ISO 10993-10); Acute systemic toxicity (ISO 10993-11); Hemocompatibility (ISO 10993-4); Materials-Mediated Pyrogenicity. | Cytotoxicity (ISO 10993-5); Sensitization (ISO 10993-10); Irritation (ISO 10993-10); Acute systemic toxicity (ISO 10993-11); Hemocompatibility (ISO 10993-4); Materials-Mediated Pyrogenicity. (Identical) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes a substantial equivalence submission, not a new clinical study with a defined test set for a new device. The performance data provided is primarily:
- Bench Testing: Mechanical testing on the XSTAT 30 applicator (Deployment Force, Plunger Axial Force, Tip Tensile Strength, Fluid Immersion). No specific sample sizes are mentioned, but these are typically done on multiple units.
- Minisponges: The minisponges are stated to be "identical to the predicate devices." Therefore, prior testing for the predicate (K170334), including radiopacity, immunogenicity, absorption capacity, extent of swelling, expansion force/pressure, and viral inactivation, is referenced.
- Biocompatibility Testing: Similar to minisponges, this testing was performed on the predicate devices (K170334) and referenced, as the minisponges are identical.
- Animal Study: The animal performance testing was also conducted on the predicate devices (K170334) and referenced.
There is no specific test set sample size or data provenance mentioned for a new clinical study in this document. The "tests" are primarily bench and referenced pre-clinical data from the predicate.
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. This is not a study involving expert readers or ground truth establishment in the context of an AI/ML device or diagnostic test.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving expert adjudication.
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 not an AI/ML device or a diagnostic device where MRMC studies would typically be conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical hemostatic device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the chemical and mechanical properties, the "ground truth" is established through standardized laboratory testing (e.g., ISO standards for biocompatibility). For clinical effectiveness, it refers to the performance demonstrated in animal studies and potentially human experience with the predicate devices, against which the new device is deemed "substantially equivalent" because its active components and mechanism of action are identical.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 878.4452 Nonabsorbable expandable hemostatic sponge for temporary internal use.
(a)
Identification. A nonabsorbable expandable hemostatic sponge for temporary internal use is a prescription device intended to be placed temporarily into junctional, non-compressible wounds, which are not amenable to tourniquet use, to control bleeding until surgical care is acquired. The sponges expand upon contact with blood to fill the wound cavity and provide a physical barrier and pressure that facilitates formation of a clot. The device consists of sterile, nonabsorbable radiopaque compressed sponges and may include an applicator to facilitate delivery into a wound.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Performance data must demonstrate the biocompatibility of patient-contacting components.
(2) Performance data must demonstrate the sterility of patient-contacting components including endotoxin and pyrogenicity assessments.
(3) Performance data must support device stability by demonstrating continued sterility of the patient-contacting components of the device, package integrity, and device functionality over the requested shelf life.
(4) Assessment of material characteristics must be sufficient to support safety under anticipated conditions of use. Assessments must include the following:
(i) Material specifications.
(ii) Immunogenicity.
(iii) Viral inactivation for animal-derived materials.
(5) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Absorption capacity.
(ii) Extent of swelling.
(iii) Mechanical properties.
(iv) Expansion force/pressure.
(v) Radiopacity.
(vi) Deployment/applicator functionality.
(6) In vivo performance data must demonstrate safe and effective use by verifying that the device performs as intended under anticipated conditions of use. Appropriate analysis/testing must demonstrate that the product: Controls bleeding, does not promote adverse local or systemic effects, and can be completely removed from the wound. The following performance characteristics must be tested:
(i) Deployment.
(ii) Control of bleeding.
(iii) Radiopacity.
(iv) Retrieval.
(v) Assessment of local and systemic effects.
(7) Human factors testing and analysis must validate that the device design and labeling are sufficient for appropriate use by emergency responders deploying the device as well as surgeons retrieving the device from wounds.
(8) Labeling must include:
(i) Specific instructions for deployment by emergency responders and retrieval by surgeons.
(ii) Warnings, cautions, and limitations needed for safe use of the device.
(iii) Information on how the device operates and the typical course of treatment.
(iv) A detailed summary of the in vivo and human factors testing pertinent to use of the device.
(v) Appropriate imaging information to ensure complete retrieval of device.
(vi) An expiration date/shelf life.