(463 days)
No
The device description and performance studies focus on the material properties and hemostatic function of a physical patch, with no mention of AI/ML or related concepts.
Yes
The device is indicated for temporary control of internal organ space bleeding and for control of severely bleeding wounds and traumatic injuries, which are therapeutic applications.
No
The device is described as a "surgical hemostatic patch" indicated for "temporary control of internal organ space bleeding" and "control of severely bleeding wounds and traumatic injuries." Its function is to stop bleeding, which is a therapeutic rather than a diagnostic action.
No
The device description clearly states it is a "sterile, single-use, surgical hemostatic patch" composed of physical materials (chitosan pad, viscose-polyester gauze, radiopaque element), indicating it is a hardware medical device, not software-only.
Based on the provided information, the Ax-Surgi device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "temporary control of internal organ space bleeding" and "control of severely bleeding wounds and traumatic injuries." This describes a device used on or in the body to treat a condition, not a device used to examine specimens from the body to diagnose a condition.
- Device Description: The description of a "sterile, single-use, surgical hemostatic patch" composed of chitosan and gauze further supports its use as a therapeutic or procedural device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, tissue, etc.) outside of the body, which is the defining characteristic of an IVD.
- Performance Studies: The performance studies focus on hemostasis (stopping bleeding) in animal models and various biocompatibility and physical property tests. These are typical evaluations for a surgical device, not an IVD.
In summary, the Ax-Surgi is a surgical hemostatic device used directly on the patient to control bleeding, not a device used to perform diagnostic tests on samples.
N/A
Intended Use / Indications for Use
The Ax-Surgi is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds and traumatic injuries.
Product codes (comma separated list FDA assigned to the subject device)
POD
Device Description
The Ax-Surgi Surgical Hemostat Surgical Hemostat is a sterile, single-use, surgical hemostatic patch. It is composed of a soft, lyophilized chitosan pad attached to a standard viscose-polyester gauze with a radiopaque element.
The lyophilized chitosan pad component of Ax-Surgi Surgical Hemostat is identical in material, composition, manufacturing, and biocompatibility to the legally marketed Axiostat Patch K202830, except that it is attached to a viscose-polyester gauze with a radiopaque element. The viscose-polyester gauze backing provides greater wet strength to the chitosan pad and the radiopaque element allows for detection via X-ray.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Internal organ space, severely bleeding wounds
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)
Animal Studies Pilot study: “To evaluate the safety and performance of chitosan hemostatic dressing in non- heparinized porcine hepatic resection model (48hr and 28 days non-GLP)”.
Pivotal study: "Evaluation of Safety and Hemostatic Performance of the Ax-Surgi Chitosan Surgical Hemostat in a Liver Resection Model in Swine, 48 Hours and 28 Day."
Results: Ax-Surgi Surgical Hemostat achieved successful safety and performance assessment in a pilot non-GLP and a pivotal study conducted in porcine hepatic resection model. Both the pilot and pivotal animal studies demonstrated that the Ax-Surgi Surgical Hemostat was safe to be used as a hemostatic dressing for temporary internal use. During the pivotal study, Ax-Surgi Surgical Hemostat achieved successful hemostasis in a swine liver resection model displaying class III or class IV bleeding. The hemostatic performance and safety of Ax-Surgi Surgical Hemostat was compared with the standard of care as control group. This study evaluated inflammation, adhesion formation, systemic and local toxicity according to ISO 10993-06 and ISO 10993-11 and the local effect after implantation as compared to the predicate device. The preclinical studies demonstrated that the subject device is; Able to achieve hemostasis, Can be radiographically detected, Inflammation and adhesions associated with the device were as expected for this type of surgery (laparotomy and liver resection) and were substantially equivalent to the standard of care. No evidence of vascular obstruction or embolization. The results of the study were satisfactory and met necessary safety end points as per special controls mentioned in Regulation no. 21 CFR 878.4454 and the study results support the substantial equivalence of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4454 Non-absorbable, hemostatic gauze for temporary internal use.
(a)
Identification. A non-absorbable, hemostatic gauze for temporary internal use is a prescription device intended to be placed temporarily for control of severely bleeding wounds such as surgical wounds and traumatic injuries. The gauze is coated or impregnated with a hemostatic material which may enhance hemostasis by physical means. The device is intended to be removed once the patient is stabilized.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Specifically testing must:
(i) Demonstrate that the device is able to achieve hemostasis;
(ii) Demonstrate that the device can be radiographically detected; and
(iii) Assess pertinent safety endpoints including vascular obstruction and adhesion formation.
(2) The device must be demonstrated to be biocompatible.
(3) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following tests must be performed:
(i) In vitro clot assessment;
(ii) Particulate release testing;
(iii) Physical characterization, including swelling percent and particulate size;
(iv) Chemical characterization;
(v) Radiopacity testing; and
(vi) Mechanical integrity testing, including tensile strength and tear strength.
(4) Performance data must demonstrate the sterility of the device.
(5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(6) Labeling must include the following:
(i) Instructions for use, including an instruction to remove all visible device components by irrigation;
(ii) The maximum amount of time the device may be left within the body;
(iii) A shelf life;
(iv) A contraindication for intravascular use of the device; and
(v) A warning regarding the potential for adhesion formation.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, there is a blue square with the letters 'FDA' in white. Next to the blue square, the words 'U.S. FOOD & DRUG ADMINISTRATION' are written in blue.
Advamedica Inc. % Ainoa Forteza Vice Director Regulatory Consultant Alira Health Avinguda Josep Tarradellas, 123 (7th Floor), Barcelona, 08029 ESP
Re: K213198
Trade/Device Name: Ax-Surgi Surgical Hemostat Regulation Number: 21 CFR 878.4454 Regulation Name: Non-Absorbable, Hemostatic Gauze For Temporary Internal Use Regulatory Class: Class II Product Code: POD Dated: September 28, 2021 Received: September 29, 2021
Dear Ainoa Forteza:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows the name "Deborah A. Fellhauer" in a clear, sans-serif font. Below the name, there is a "-S". The text is positioned against a background that includes a faded, light blue watermark of the letters "FDA".
Deborah Fellhauer, RN, BSN Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
4. INDICATIONS FOR USE STATEMENT
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Ax-Surgi Surgical Hemostat
Indications for Use (Describe)
The Ax-Surgi is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds and traumatic injuries.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
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FORM FDA 3881 (6/20)
Page 1 of 1
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510(k) Summary K213198 Ax-Surgi Surgical Hemostat (per 21CFR 807.92)
Date: January 5, 2023
1. 510K APPLICANT / SUBMITTER
Advamedica Inc., Harvard Square, 1 Mifflin Place, Suite 400 Cambridge, MA 02138, USA Email: office(@advamedica.com Telephone: +1 973-718-7575
2. SUBMISSION CONTACT PERSON
Ainoa Forteza Alira Health Avinguda Josep Tarradellas, 123 (7th Floor) 08029 Barcelona, Spain Email: ainoa.forteza@alirahealth.com
3. DEVICE NAME
Proprietary Name: Ax-Surgi Surgical Hemostat Common/Usual Name: Temporary, internal use hemostat Classification Name: Non-absorbable hemostatic gauze for temporary internal use Device Classification: II Regulation Number: 21 CFR 878.4454 Product Code: POD
4. PREDICATE DEVICES
Primary Predicate- QuikClot Control+ Hemostatic Dressing - K200167 Reference Predicate - Axiostat Patch K202830
ട. DEVICE DESCRIPTION
4
The Ax-Surgi Surgical Hemostat Surgical Hemostat is a sterile, single-use, surgical hemostatic patch. It is composed of a soft, lyophilized chitosan pad attached to a standard viscose-polyester gauze with a radiopaque element.
The lyophilized chitosan pad component of Ax-Surgi Surgical Hemostat is identical in material, composition, manufacturing, and biocompatibility to the legally marketed Axiostat Patch K202830, except that it is attached to a viscose-polyester gauze with a radiopaque element. The viscose-polyester gauze backing provides greater wet strength to the chitosan pad and the radiopaque element allows for detection via X-ray.
INTENDED USE 6.
The Ax-Surgi Surgical Hemostat is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries.
7. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
Ax-Surgi Surgical Hemostat is substantially equivalent to the predicate device, QuikClot Control+ Hemostatic Dressing, with respect to device characteristics and intended use. Table 5-1 on the next page provides a comparison of the technological and design characteristics of the subject device to the predicate.
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Table 5-1:Comparison with Predicate Devices
| | Subject Device | Predicate Device | Reference
Device | Comparison |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K213198 | K200167 | K202830 | |
| Trade Name | Ax-Surgi Surgical Hemostat | QuikClot Control+
Hemostatic Dressing | Axiostat Patch | |
| Manufacturer | Advamedica Inc. | Z-Medica LLC | Advamedica, Inc. | |
| Indications
for Use | The Ax-Surgi Surgical Hemostat
is indicated for temporary
control of internal organ space
bleeding for patients displaying
class III or class IV bleeding. It
may also be used for control of
severely bleeding wounds such
as surgical wounds and
as traumatic injuries. | QuikClot Control+ is indicated
for temporary control of
internal organ space bleeding
for patients displaying class III
or class IV bleeding. It may
also be used for control of
severely bleeding wounds such
as surgical wounds and
as traumatic injuries | The Axiostat Patch is intended for local
management of bleeding wounds and to
provide a barrier to bacterial
penetration of the dressing for patients
and for the rapid control of moderate to
severe bleeding. The dressing is
indicated for the following wounds:
lacerations, abrasions, surgical
debridement sites, skin surface
puncture sites, vascular procedure sites
and sites involving percutaneous
catheters, tubes and pins. | Same |
| Active
Material | Chitosan | Kaolin | Chitosan | Similar
The hemostatic agent in Ax-Surgi
Surgical Hemostat uses chitosan
while the hemostatic agent in the
predicate QuikClot Control+ device
is kaolin.
See Note 1. |
6
| Device
Design/
Composition | Chitosan pad attached to a
rayon-polyester gauze
backing containing a
radiopaque thread | Non-absorbable device
containing kaolin bound to
gauze. The dressing is x-ray
detectable. | Chitosan pad | Similar, the difference is not
expected to raise any concerns in
terms of safety and effectiveness.
See Note 2. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Non-
absorbable | Yes | Yes | Yes | Same |
| X-ray
detectable | Yes | Yes | No | Same |
| Mechanism
of Action | Absorption of plasma by the
chitosan pad, which results in
physical aggregation of blood
cells and clotting factors at the
site of application. In addition,
when applied with pressure,
Ax-Surgi Surgical Hemostat
creates a mechanical barrier
against bleeding | Hemostasis is achieved
through the activity of the
hemostatic agent kaolin
bound to the gauze in
conjunction with
compression | Absorption of plasma by the chitosan
pad, which results in physical
aggregation of blood cells and clotting
factors at the site of application. In
addition, when applied with pressure,
Axiostat Patch creates a mechanical
barrier against bleeding | the difference is not
Similar,
expected to raise any concerns in
terms of safety and effectiveness.
See Note 3. |
| Sterilization
method | Gamma radiation | Gamma radiation | Gamma radiation | Same |
Note 1:
Both chirosan and kaolin are non-abordable hemostals, the difference in the hemostate agent between the subject and procents no additional issues of safety or effectiveness.
Note 2:
Both the proposed and primary predicate devices are composed of material to be biocompatible and hemostatic. The use of chitosan in the proposed Ax-Surgical Hemostat device compared to kaolin-impregated gauze does not present any new issues of safety or effectiveness as evident from the extensive preclinical, bocompatibility, animal testing and proposed Ax-Surgi Surgical Hemostat and the reference device, Axiostal in design in that both pads are composed of 10% chiosan. The proposed Hemotat differs in that it is attached to a visoose-polyester gauze backing ontaining a radiopaque thread to support the revised indications for use. These are nocompatibility testing has been conducted the backing is safe for its intended use and that there are no new issues of safety.
7
Note 3:
Both Ax-Surgical Hemostat and the predicate Quilt Control+ Hemostato Dressing hemostasis by physical means through the activity of a hemostatic agent in compression. Both the proposed Ax-Surgi Surgical Hemostat and the predicate QuikClot Control + devices are to be used to apply pressure to an internal wound until bled. The hemostatic agent in Ax-Surgi Surgical Hemostations while the hemoratio agent in the predicate Quick Control+ device is kaoin. Both the proposed Ax-Surgical Hemosta and the Axiostal in that hey operate by absorpion of plasma by the chitosan pad, which results in physical aggregation of blood cells at the site of application. In addition, when applied with pressure, both devices create a mechanical barrier against bleeding.
Nor-clinical testing has been conducted the safety and performance of Ax-Surgi Surgical Hemostat. The results from all the testing conducted confirms that Ax-Surgical Hemostat is as safe and as effective as the predicate in its intended use and that it is substantially equivalent to the predicate and reference devices.
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8. PERFORMANCE TESTING
Table 5-2 lists all of the testing that has been performed on Ax-Surgi Surgical Hemostat.
| Testing | Results |
|---|---|
| Cytotoxicity | Non-cytotoxic |
| Sensitization | Non-sensitizing |
| Genotoxicity | Non-mutagenic |
| Acute Systemic Toxicity | Non-toxic |
| Implantation | Non-toxic |
| Pyrogenicity | Non-pyrogenic |
| Subacute Toxicity | Non-toxic |
| Intracutaneous Reactivity | Non-irritating |
| Hemolysis Test | Non-hemolytic |
| Animal Studies Pilot study on “To evaluate the safety and performance of chitosan hemostatic dressing in non- heparinized porcine hepatic resection model (48hr and 28 days non-GLP)” Pivotal study on "Evaluation of Safety and Hemostatic Performance of the Ax-Surgi Chitosan Surgical Hemostat in a Liver Resection Model in Swine, 48 Hours and 28 Day." | Ax-Surgi Surgical Hemostat achieved successful safety and performance assessment in a pilot non-GLP and a pivotal study conducted in porcine hepatic resection model. Both the pilot and pivotal animal studies demonstrated that the Ax-Surgi Surgical Hemostat was safe to be used as a hemostatic dressing for temporary internal use. During the pivotal study, Ax-Surgi Surgical Hemostat achieved successful hemostasis in a swine liver resection model displaying class III or class IV bleeding. The hemostatic performance and safety of Ax-Surgi Surgical Hemostat was compared with the standard of care as control group. This study evaluated inflammation, adhesion formation, systemic and local toxicity according to ISO 10993-06 and ISO 10993-11 and the local effect after implantation as compared to the predicate device. The preclinical studies demonstrated that the subject device is; Able to achieve hemostasis Can be radiographically detected Inflammation and adhesions associated with the device were as expected for this type of surgery (laparotomy and liver resection) and were substantially equivalent to the standard of care. No evidence of vascular obstruction or embolization The results of the study were satisfactory and met necessary safety end points as per special controls mentioned in Regulation no. 21 CFR 878.4454 and the study results support the substantial equivalence of the device |
Table 5-2: Ax-Surgi Surgical Hemostat Testing
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| Moisture Content | Pass |
|---|---|
| Tensile Strength | Pass |
| Integrity | Pass |
| Radiopacity | Pass |
| In vitro Clot Assessment | Pass |
| Particulate Release | Pass |
| Absorbency | Pass |
| pH | Pass |
9. STERILIZATION AND PACKAGING
Ax-Surgi Surgical Hemostat is provided sterile in a moisture proof packs. The product is terminally sterilized gamma sterilization to a sterility assurance level (SAL) of 10th. The dose of gamma radiation has been optimized and validated per ISO 11137-2.
Following gamma sterilization, the package integrity was subjected to sterile barrier testing to validate a shelf life of 18 months. The stability and effectiveness of packaging of the sterilized product during the shelf life was confirmed by real time study.
After a real time, aging period of 18 months, testing conducted demonstrates that Ax-Surgi Surgical Hemostat retains sterility, functionality, and its physical characteristics. The tests results demonstrate that Ax-Surgi Surgical Hemostat dressings stored for a period of 18 months are safe and effective for their intended use.
10. CONCLUSION
The subject device complies with special controls as identified in 21 CFR 878.4454 "Nonabsorbable, hemostatic gauze for temporary internal use". Based on the information provided in this 510(k) premarket notification, Advamedica Inc. concludes that Ax-Surgi Surgical Hemostat is substantially equivalent to the predicate device. QuikClot Control+ Hemostatic Dressing.