(239 days)
Not Found
No
The device description and performance studies focus on the material properties and physical mechanism of action of the dressing, with no mention of AI or ML.
Yes
The device is described as a hemostatic dressing indicated for managing topical wounds and controlling external surface bleeding, which are therapeutic actions.
No
Explanation: The Suntouch Topical Hemostatic Dressing is designed to manage bleeding and topical wounds by forming a gel, which is a therapeutic function, not a diagnostic one. It does not analyze or interpret physiological data to identify a disease or condition.
No
The device description clearly states it is a physical dressing made from regenerated cotton cellulose, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of topical wounds and temporary control of external surface bleeding. This involves direct application to the body surface to physically interact with blood and promote clotting.
- Device Description: The device is a dressing made from treated cellulose that forms a gel upon contact with blood and exudates. This is a physical mechanism for wound management and hemostasis.
- Lack of In Vitro Diagnostic Characteristics: An IVD is a medical device that is used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to provide information about a person's health. This device does not perform any such tests on samples. It is applied directly to the wound.
- Performance Studies: The performance studies described focus on in-vivo (on a living organism, swine) and in-vitro (in a lab setting, but not on human samples for diagnostic purposes) tests related to its hemostatic function, not diagnostic capabilities.
Therefore, the Suntouch Topical Hemostatic Dressing is a topical wound dressing with hemostatic properties, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Suntouch Topical Hemostatic Dressing is indicated for the management of topical wounds and to temporary control of external surface bleeding.
All gauze are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006.
Suntouch Topical Hemostatic Dressing is indicated for temporary external topical bleeding of minor cuts, minor lacerations, and it is contraindicated for internal use.
All gauze are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006.
Product codes (comma separated list FDA assigned to the subject device)
QSY, FRO
Device Description
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)
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)
Stop bleeding tests were conducted on swine neck artery wound and were conducted side by side with the predicate device. As shown from Table 5.2, times needed for Suntouch Dressing to stop bleeding, and the blood loss in 120 min period, are comparable to the predicate device.
In Vitro Procoagulant Test was also conducted for our Suntouch Topical Hemostatic Dressing. Our device can rapidly clot the blood even under anti-coagulate agent, further demonstrated its effectiveness in controlling bleeding.
Biocompatibility tests were conducted following procedures outlined in the respective consensus standards, and results for Suntouch Topical Hemostatic Dressing met all relevant requirements in the test standards, and are comparable to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Average Stop Bleeding Time on Swine Neck Artery Wound: 55.0 minute (vs. 108.75 min for control dressing)
- Average Blood Loss on Swine Neck Artery Wound: 82.6 gram (vs. 163.84 g for control dressing)
- In Vitro Procoagulant Test: Test Group Clog in 34 Second, Blank Control Group Does not Clog
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.
Not Found
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
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Huizhou Foryou Medical Devices Co, Ltd c/o Manton Business and Technology Services Chengyu Shen Manager 5 Carey Street Pennington, New Jersey 08534
July 28, 2023
Re: K112800 Trade/Device Name: Suntouch Topical Hemostatic Dressing Regulatory Class: Unclassified Product Code: QSY
Dear Chengyu Shen:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 23, 2012. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSY.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.
Sincerely, Julie A. Morabito -S
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 2 3 2012
Huizhou Foryou Medical Devices Co., Ltd % Manton Business and Technology Services Chengyu Shen Manager 5 Carey Street Pennington, New Jersey 08534
Re: K112800
Trade/Device Name: Suntouch Topical Hemostatic Dressing Regulation Class: Unclassified Product Code: FRO Dated: April 24 , 2012 Received: April 24, 2012
Dear Chengyu Shen:
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. 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 statutes and regulations administered by other Federal agencies. You must
2
Page 2 – Chengyu Shen
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.btm.
Sincerely yours,
Fon
Mark N. Melke Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
Section 4: Indications for Use
Section 4: Indication for Use Statement
K112800 510(k) Number (if known):
Device Name: Suntouch Topical Hemostatic Dressing
Indications for Use:
Prescription:
Suntouch Topical Hemostatic Dressing is indicated for the management of topical wounds and to temporary control of external surface bleeding.
All gauze are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006.
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.
All gauze are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
1
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Stone for mm
(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112800
Section 4: Indication Section 4 page
4
K112800
Page 1 of 6
MAY 2 3 2012
Section 5: 510(k) Summary:
This summary of 510k safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92
Submitter & Foreign Manufacture Identification
Huizhou Foryou Medical Devices Co., Ltd. No.1. Shangxia North Road. Dongjiang Hi-Tech Industry Park, Huizhou, Guangdong Province, China Tel: (086) 0752-5302013 Submitter's FDA Registration Number: 3007735241
US Agent and Contact Person
Chengyu Shen Manton Business and Technology Services 5 Carey Street Pennington, NJ 08534 Tel: 608-217-9358 Email: cyshen@aol.com
Date of Summary: Sept 22, 2011
Device Name:
Trade Name: : Common Name: Classification Name: Product Code: Regulation Number: Review Panel:
Suntouch Topical Hemostatic Dressing Hemostatic Wound Dressing Dressing; wound, Drug FRO Unclassified General & Plastic Surgery
Predicate Device Information:
- (1) K072681, "Bloodstop Hemostatic Gauze; Ix Hemostatic Gauze", manufactured by "Lifescience Plus, Inc" located in Mystic, CT 06355
- (2) K071578, " Bloodstop And Bloodstop IX Hemostatic Gauze", manufactured by "Lifescience Plus, Inc" located in Mystic, CT 06355
Device description:
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.
Section 5: 510k Summary Section 5 p 1
5
K112800
page 2 of 6
The gauzes are sold in the following forms: Sheet, rolls, and pack (four layers)
List of all Forms and Sizes Involved in this Submission Table 5.1
| Design Form | Size |
|---|---|
| Sheet | 25 x 25 mm, 50 x 30 mm, 50 x 50 mm, 50 x 70 mm, 100 x |
| 100 mm, 120 x 80 mm, 160 x 140 mm, 200 x 100 mm | |
| Other sizes requested by distributors | |
| Roll | 12 x 5 mm (Width x diameter) |
| Other sizes requested by distributors | |
| Pack (four layers) | 11 x 11 mm |
| 19x19 mm | |
| Other sizes requested by distributors |
All gauze are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006.
Intended Use:
Prescription:
Suntouch Topical Hemostatic Dressing is indicated for the management of topical wounds and to temporary control of external surface bleeding.
All gauze are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006.
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.
All gauze are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006.
Comparison to Predicate Devices
Suntouch Topical Hemostatic Dressing is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance.
- (1) K072681, "Bloodstop Hemostatic Gauze; Ix Hemostatic·Gauze", manufactured by "Lifescience Plus, Inc" located in Mystic, CT 06355
- (2) K071578, " Bloodstop And Bloodstop IX Hemostatic Gauze", manufactured by "Lifescience Plus, Inc" located in Mystic, CT 06355
Section 5 p 2 Section 5: 510k Summary
6
K 11 2800
Page. 396
The following table shows similarities and differences of use, design, material, and processing methods between our device and the predicate devices. T
Table 5.1: Comparison of Intended Use, Design, and Material
| Description | Our Device | Predicate Device 1
(K072681) | Predicate Device 1
(K071578) |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| | Prescription:
Suntouch Topical Hemostatic Dressing is
indicated for the management of topical
wounds and to temporary control of
external surface bleeding. | | |
| Indication for
Use | All gauze are sterilized and sold directly
to users after sterilization by radiation
using conditions validated following ISO
11137-2: 2006.
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.
All gauze are sterilized and sold directly
to users after sterilization by radiation
using conditions validated following ISO | Non-absorbable hemostatic
gauze for OTC, emergency
and therapeutic use.
It is used for the control of
bleeding from the skin and
other surface wounds
where temporary control of
bleeding is required. | Topical control of
bleeding of minor
cuts and abrasions of
skin surface |
| | 11137-2: 2006. | | |
| Prescription/O
TC | Prescription and OTC | Prescription | OTC |
| Mechanism | When contacting blood and exudates, they
expand into clear gel, thereby adhering
and creating pressure to seal the wound. | Same | Same |
| Materials | Regenerated cotton cellulose | Same (Identical Infrared
Spectrum) | Same (Identical
Infrared Spectrum) |
| Chemical
Treatment | Oxidized and etherized to become water-
soluble | Oxidized and etherized to
become water-soluble | Oxidized and
etherized to become
water-soluble |
| Single Use | Yes | Yes | Yes |
| Sterile | Sterile | Sterile | Sterile |
7
Infrared Spectroscopy is a powerful technique in elucidate the structure of chemical materials. Each functional group inside a molecule has its unique infrared absorption, so each peak in an infrared spectrum is regarded as the "finger print" of a functional group inside the molecule.
We recorded the infrared spectra of Suntouch Topical Hemostatic Dressing and BloodStop Gauze and they are summarized below. The almost identical spectra indicated both devices are very similar in chemical structure.
Image /page/7/Figure/4 description: The image shows two infrared spectrum graphs. The first graph is labeled "Suntouch Topical Hemostatic Dressing", and the second graph is labeled "Predicate Device 1 (K071578)". Both graphs show similar patterns, with a large peak around 3300 and smaller peaks between 1000 and 1750. The graphs are used to compare the infrared spectrum of the two products.
Therefore, Suntouch Topical Hemostatic Dressing and its predicate devices are both made from regenerated cotton cellulose, underwent the same chemical treatment to become water soluble, have same chemical structure, and utilize the same bleeding control mechanism. They are both indicated for temporary external topical bleeding.
The following table (Table 5.2) shows similarities and differences of the hemostatic performance between our device and the predicate devices. (Experimental details can be found in Section 19)
8
K112800
page 596
| Description | Our Device | Predicate Device 1
(K072681) | Predicate Device 2
(K071578) |
|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|------------------------------------------------------|---------------------------------------------------------|
| Average Stop Bleeding Time
on Swine Neck Artery Wound
(see Section 19 for test details) | 55.0 minute
(vs. 108.75 min for
control dressing) | Same as Predicate
Device 2 per
BloodStop claim | 65.0 minute
(vs. 108.75 min for
control dressing) |
| Average Blood Loss on Swine
Neck Artery Wound
(see Section 19 for test details) | 82.6 gram
(vs. 163.84 g for control
dressing) | Same as Predicate
Device 2 per
BloodStop claim | 81.9 gram
(vs. 163.84 g for
control dressing) |
| In Vitro Procoagulant Test
(Internal Test Procedure) | Test Group Clog in 34
Second, Blank Control
Group Does not Clog | Not tested | Not tested |
Table 5.2: Comparison of Hemostatic Performance of Suntouch and BloodStop Dressings
Stop bleeding tests were conducted on swine neck artery wound and were conducted side by side with the predicate device. As shown from Table 5.2, times needed for Suntouch Dressing to stop bleeding, and the blood loss in 120 min period, are comparable to the predicate device. More details of tests are summarized in Section 19.
In Vitro Procoagulant Test was also conducted for our Suntouch Topical Hemostatic Dressing. Our device can rapidly clot the blood even under anti-coagulate agent, further demonstrated its effectiveness in controlling bleeding. More details of the test can be found in Section 18. There is no similar data available for predicate device for this test.
The following table (Table 5.3) shows similarities and differences of the biocompatibility performance between our device and the predicate devices.
Biocompatibility tests were conducted following procedures outlined in the respective consensus standards, and results for Suntouch Topical Hemostatic Dressing met all relevant requirements in the test standards, and are comparable to the predicate device. More details of biocompatibility tests are summarized in Section 15.
Section 5 p 5 Section 5: 510k Summary
9
K. 112800
page 6 of 6
| Description | Our Device | Predicate Device 1 (K072681) | Predicate Device 2 (K071578) |
|---|---|---|---|
| Cytotoxicity | No Toxic Effect | ||
| (ISO10993-5) | |||
| Skin Irritation and | |||
| Sensitization | No Effect | ||
| (ISO 10993-10) | Biocompatible | Biocompatible | |
| Systematic Toxicity | No Effect (ISO 10993-11) | ||
| Pyrogenicity | No Effect (ISO 10993-11) |
Table 5.3: Comparison of Biocompatibility Performance Testing
A brief discussion of the non-clinical testing data that was submitted, referenced or relied on to demonstrate that the Subject Device is safe and effective, and whose performance meets the requirements of its user-defined acceptance criteria and intended uses:
Suntouch Topical Hemostatic Dressing meets biocompatibility requirements per ISO. 10993-5, ISO 10993-10, and ISO 10993-11 (acute system toxicity and pyrogenicity). It's physical and performance meets the requirements of its pre-defined acceptance criteria and intended uses. All dressings are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006. The product is safe and effective for its intended use.
A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence.
Clinical data is not needed for wound dressing or for most devices cleared by the 510(k) process.
Substantial Equivalent Statement
Based on the comparison of intended use, design, materials, and performance, our Suntouch Topical Hemostatic Dressing is substantial equivalent to its predicate devices.