(692 days)
Not Found
No
The device description and performance studies focus on the physical and biological properties of the chitosan powder for hemostasis, with no mention of AI or ML.
Yes
This device is intended to be used in emergency situations for the temporary control of severe topical bleeding and for the local management of minor bleeding, both of which are therapeutic interventions.
No
The device, S.E.A.L. Hemostatic Wound Spray, is intended to achieve hemostasis and control bleeding by forming a physical barrier/seal. It is a treatment device, not one that identifies or characterizes a disease or condition.
No
The device is a physical wound spray composed of chitosan powder, not software. The description details its physical form and mechanism of action.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to achieve hemostasis (stop bleeding) topically on wounds. This is a direct therapeutic action on the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is a sprayable powder that forms a physical barrier on the wound. This mechanism of action is for wound management, not for analyzing a biological sample to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) to provide diagnostic information. The device interacts directly with the wound and blood to stop bleeding.
- Performance Studies: The performance studies focus on hemostatic efficacy in vitro (coagulation test) and in vivo (animal models), as well as biocompatibility. These are relevant to a topical hemostatic device, not an IVD.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
Indications for Use (Describe)
Prescription Use:
- S.E.A.L. Hemostatic Wound Spray is intended to be used to achieve hemostasis in emergency situations for the temporary control of severe topical bleeding.
OTC:
- S.E.A.L. Hemostatic Wound Spray is indicated for the local management of minor bleeding such as minor lacerations, minor cuts and minor abrasions.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
S.E.A.L. Hemostatic Wound Spray is composed of chitosan dry powder in spray form that provides a physical barrier or seal to stop the flow of blood. When sprayed on a wound and upon contact with blood or exudate, in combination with manual pressure to the wound. S.E.A.L. quickly forms a strong seal that completely covers the wound. S.E.A.L. is presented for both Prescription and over-the-counter (OTC) use.
S.E.A.L. is available in three different sizes:
| Model | Volume |
|---|---|
| Small | 1.33 oz |
| Medium | 1.66 oz |
| Large | 3.33 oz |
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)
Summary of the Non-clinical Testing:
In vitro testing
Performance data were provided in support of the substantial equivalence determination. The characteristics of the S.E.A.L. Hemostatic Wound Spray were substantially equivalent to the predicate device. S.E.A.L. is equivalent to CELOX in an in vitro coagulation test of porcine blood as determined by viscometry.
Animal studies
In vivo performance animal studies were done for S.E.A.L. to support substantial equivalence to Celox. A rat liver model and a standard swine hemorrhage model for efficacy assessment of topical hemostatic agents proved the substantial equivalence of S.E.A.L. and its predicate device Celox for both normal and coagulopathic animals.
In the rat liver model, S.E.A.L. showed biological safety, and no adverse effects were seen. S.E.A.L. was assessed as efficient hemostatic product with non-inferiority to Celox. The functional animal study conducted in the swine model confirmed the high efficacy of S.E.A.L. to achieve hemostasis, with no statistically significant differences in bleeding time, blood loss and survival time compared to Celox. Moreover, both gross necropsy and histopathology did not show any signs of tissue or organ damage related to the application of the device. Also, thromboemboli have not been developed in the surrounding tissues or other areas, and the risk of a thromboemboli migration to critical structures was also ruled out. S.E.A.L. proved to be as efficient and safe as Celox.
Summary of the Biocompatibility Testing:
The biocompatibility evaluation of the final, finished device was conducted in accordance with FDA guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"". S.E.A.L. is a device for breached or compromised surface with limited contact duration (
N/A
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 2, 2023
BC3 Technologies Inc Wayne Grube CEO 3701-A Southwestern Blvd Baltimore, Maryland 21229
Re: K210751
Trade/Device Name: S.E.A.L. Hemostatic Wound Spray Regulatory Class: Unclassified Product Code: FRO Dated: December 20, 2022 Received: December 20, 2022
Dear Wayne Grube:
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 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 mediation-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.
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
Enclosure
2
Indications for Use
510(k) Number (if known) K210751
Device Name S.E.A.L. Hemostatic Wound Spray
Indications for Use (Describe)
Prescription Use:
· S.E.A.L. Hemostatic Wound Spray is intended to be used to achieve hemostasis in emergency situations for the temporary control of severe topical bleeding.
OTC:
· S.E.A.L. Hemostatic Wound Spray is indicated for the local management of minor bleeding such as minor lacerations, minor cuts and minor abrasions.
| Type of Use (Select one or both, as applicable) | |
|---|---|
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows a logo with a heart shape that transitions from blue to red. A white line representing a heartbeat runs through the heart. To the right of the heart, the text "BC3" is written in red, with the word "Technologies" in a smaller, lighter font underneath a thin blue line. The logo appears to represent a technology company in the healthcare or medical field.
BC3 Technologies 3701-A Southwestern Blvd - Baltimore, MD 21229 e: waynegrube@bc3tech.com - www.bc3tech.com m: +1.443.204.7260 - p: +1.410.342.6100
Section 5 510(k) SUMMARY
Page 1 of 7
(as required by 807.92(c))
I. SUBMITTER
Submitter of 510(k):
BC3 TECHNOLOGIES INC 3701 Southwestern Blvd Baltimore, MD 21229 m: +1.443.204.7260 - p: +1.410.342.6100
Contact Person: Wayne L. Grube Jr. waynegrube@bc3tech.com
II. DEVICE
Name of Device: S.E.A.L. Hemostatic Wound Spray ("S.E.A.L.")
Common or Usual Name: Hemostatic wound dressing
Classification Name: Unclassified - Device, Dressing
Regulatory Class: NA
Product Code: FRO
III. PREDICATE DEVICE
Primary Predicate: CELOX Topical Hemostatic Granules (K061079) Manufactured by MedTrade Products
Supporting Predicate: Seal-On™ Hemostatic Powder Spray (K010933)
The predicate devices have not been subject to a design-related recall.
IV. DESCRIPTION
S.E.A.L. Hemostatic Wound Spray is composed of chitosan dry powder in spray form that provides a physical barrier or seal to stop the flow of blood. When
4
Image /page/4/Picture/0 description: The image shows the logo and contact information for BC3 Technologies. The logo features a heart with a heartbeat line running through it, along with the text "BC3 Technologies". The contact information includes the address "3701-A Southwestern Blvd - Baltimore, MD 21229", the email address "waynegrube@bc3tech.com", and the website "www.bc3tech.com".
m: +1.443.204.7260 - p: +1.410.342.6100
Section 5 510(k) SUMMARY
Page 2 of 7
(as required by 807.92(c))
sprayed on a wound and upon contact with blood or exudate, in combination with manual pressure to the wound. S.E.A.L. quickly forms a strong seal that completely covers the wound. S.E.A.L. is presented for both Prescription and over-the-counter (OTC) use.
S.E.A.L. is available in three different sizes:
Image /page/4/Picture/6 description: The image shows three cans of S.E.A.L. pepper spray of different sizes. The cans are black with red tops and have the word "S.E.A.L." printed vertically on the front. There is a flame logo above the word "S.E.A.L." and white stripes on either side of the word. The cans are arranged in order of size, with the smallest can on the left and the largest can on the right.
| Model | Volume |
|---|---|
| Small | 1.33 oz |
| Medium | 1.66 oz |
| Large | 3.33 oz |
V. INDICATIONS FOR USE
Prescription Use:
-
S.E.A.L. Hemostatic Wound Spray is intended to be used to achieve hemostasis ● in emergency situations for the temporary control of severe topical bleeding.
OTC: -
S.E.A.L. Hemostatic Wound Spray is indicated for the local management of ● minor bleeding such as minor lacerations, minor cuts and minor abrasions.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
5
Image /page/5/Picture/0 description: The image shows the logo for BC3 Technologies. The logo features a heart with an EKG line running through it. Below the logo is the text "BC3 Technologies" and the address "3701-A Southwestern Blvd - Baltimore, MD 21229".
e: waynegrube@bc3tech.com - www.bc3tech.com m: +1.443.204.7260 - p: +1.410.342.6100
Section 5 510(k) SUMMARY
Page 3 of 7
(as required by 807.92(c))
- MedTrade Products CELOX Topical Hemostatic Granules (K061079), which is composed of chitosan polymer, poly-N-acetylglucosamine, in dry granules form are intended (Rx) to be used to achieve hemostasis in emergency situations for the temporary control of severe topical bleeding. CELOX Topical Hemostatic Granules OTC are indicated for the local management of bleeding such as lacerations, minor cuts and abrasions. CELOX Topical Hemostatic Granules and S.E.A.L. are equivalent products since they are both chitosan-based products and have the same indications.
- Alltracel Pharma Ltd Seal-On™ Hemostatic Powder Spray (K010933), which is a powder in an aerosol form composed of a polysaccharide, indicated for OTC use in the topical control of bleeding from minor cuts and abrasions of the skin surface. Seal-On™ Hemostatic Powder Spray and S.E.A.L. are equivalent products since they are both polysaccharide-based in a powder spray form in aluminum bottle for the topical control of bleeding.
The following table compares the S.E.A.L. to the predicate devices with respect to intended use, material characteristics, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
| DEVICE COMPARISON CHART | |||
|---|---|---|---|
| Parameter | Device | Predicate Device | Reference |
| Predicative Device | |||
| Trade name | S.E.A.L. | ||
| Hemostatic Wound | |||
| Spray | CELOX Topical | ||
| Hemostatic Granules | Seal-On ™ | ||
| Hemostatic Powder | |||
| Spray | |||
| Company | |||
| Name | BC3 Technologies, | ||
| Inc. | MEDTRADE | ||
| PRODUCTS | |||
| LIMITED | Alltracel Pharma | ||
| Ltd. | |||
| 510(k) # | K210751 | K061079 | K010933 |
| Product Code | FRO | FRO | FRO |
| Hemostatic | |||
| ingredient | Chitosan, a | ||
| material consisting | |||
| of cellulosic | |||
| polymer, poly-N- | |||
| acetyl- | |||
| glucosamine | Chitosan polymer, | ||
| poly-N-acetyl- | |||
| glucosamine, in dry | |||
| granules form | Oxidized cellulose | ||
| Auxiliary | |||
| materials | Acid and | ||
| propellant | Acid and undisclosed | ||
| materials | Propellant and | ||
| undisclosed | |||
| materials | |||
| Physical | |||
| composition | Powder in an | ||
| aerosol form | Granules | Powder in an | |
| aerosol form | |||
| Particle | |||
| shape and | |||
| size | Irregular, less than | ||
| 1 mm | Not disclosed | Irregular, less than | |
| 1 mm |
DEVICE COMPARISON CHART
6
Image /page/6/Picture/0 description: The image shows a logo for BC3 Technologies. The logo features a heart shape that transitions from blue to red, with a white heartbeat line running across it. To the right of the heart, the text "BC3" is displayed in bold, red letters, with the word "Technologies" written in a smaller, lighter font underneath.
Page 4 of 7
BC3 Technologies 3701-A Southwestern Blvd - Baltimore, MD 21229 e: waynegrube@bc3tech.com - www.bc3tech.com m: +1.443.204.7260 - p: +1.410.342.6100
(as required by 807.92(c))
| Indications
For Use | Prescription Use:
S.E.A.L.
Hemostatic Wound
Spray is intended
to be used to
achieve
hemostasis in
emergency
situations for the
temporary control
of severe topical
bleeding.
OTC:
S.E.A.L.
Hemostatic Wound
Spray is indicated
for the local
management of
bleeding such as
lacerations, minor
cuts and
abrasions. | Intended (Rx) to be
used to achieve
hemostasis in
emergency situations
for the temporary
control of severe
topical bleeding.
CELOX Topical
Hemostatic Granules
OTC are indicated for
the local
management of
bleeding such as
lacerations, minor
cuts and abrasions. | Seal-On™
Hemostatic Powder
Spray is indicated
for OTC use in the
topical control of
bleeding from minor
cuts and abrasions
of the skin surface. |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Packaging
Sterilization
Method | Aluminum can
Gamma irradiation | Aluminum pouch
Gamma irradiation | Aluminum can
Gamma irradiation |
S.E.A.L. has substantially equivalent indications to Seal-On™ Hemostatic Powder Spray (K010933) and CELOX Topical Hemostatic Granules (K061079) predicates in that they are indicated for topical application as an aid in the control of temporary external bleeding associated with minor to severely bleeding wounds.
S.E.A.L. and its predicate devices are all in the form of dry particles or granules from cellulosic polymers. S.E.A.L. and its predicate devices are all sterilized by irradiation.
S.E.A.L. and Seal-On™ Hemostatic Powder Spray are substantially equivalent in that they are both based on cellulosic polymers. Both contain cellulosic polymer as the hemostatic ingredient. Both contain particles and they are both packaged in aluminum packaging. Both devices are in the form of an aerosol. Both products use a propellant that belongs to the same class of non-flammable gases.
S.E.A.L. and CELOX Topical Hemostatic Granules are substantially equivalent in that they are both composed of chitosan. Both contain chitosan as the hemostatic ingredient. Both are in the form of dry particles/granules. They are both intended to be used (Rx) to achieve hemostasis in emergency situations for the temporary control of severe topical bleeding.
7
Image /page/7/Picture/0 description: The image shows the logo and contact information for BC3 Technologies. The logo features a heart with a white line running through it, along with the text "BC3 Technologies". The contact information includes the address 3701-A Southwestern Blvd - Baltimore, MD 21229, the email address waynegrube@bc3tech.com, the website www.bc3tech.com, and the phone numbers +1.443.204.7260 and +1.410.342.6100.
Page 5 of 7
(as required by 807.92(c))
To prove that minor differences in ingredient do not raise different questions of safety and effectiveness and that S.E.A.L. is as safe and efficacious as its predicate devices, a series of tests were done as described below.
VII. PERFORMANCE DATA
Summary of the Non-clinical Testing:
In vitro testing
Performance data were provided in support of the substantial equivalence determination. The characteristics of the S.E.A.L. Hemostatic Wound Spray were substantially equivalent to the predicate device. S.E.A.L. is equivalent to CELOX in an in vitro coagulation test of porcine blood as determined by viscometry.
Animal studies
In vivo performance animal studies were done for S.E.A.L. to support substantial equivalence to Celox. A rat liver model and a standard swine hemorrhage model for efficacy assessment of topical hemostatic agents proved the substantial equivalence of S.E.A.L. and its predicate device Celox for both normal and coagulopathic animals.
In the rat liver model, S.E.A.L. showed biological safety, and no adverse effects were seen. S.E.A.L. was assessed as efficient hemostatic product with non-inferiority to Celox. The functional animal study conducted in the swine model confirmed the high efficacy of S.E.A.L. to achieve hemostasis, with no statistically significant differences in bleeding time, blood loss and survival time compared to Celox. Moreover, both gross necropsy and histopathology did not show any signs of tissue or organ damage related to the application of the device. Also, thromboemboli have not been developed in the surrounding tissues or other areas, and the risk of a thromboemboli migration to critical structures was also ruled out. S.E.A.L. proved to be as efficient and safe as Celox.
Summary of the Biocompatibility Testing:
The biocompatibility evaluation of the final, finished device was conducted in accordance with FDA guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"". S.E.A.L. is a device for breached or compromised surface with limited contact duration (