(692 days)
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.
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.
The S.E.A.L. Hemostatic Wound Spray's acceptance criteria and the studies that demonstrate its compliance are detailed below. It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo acceptance criteria and performance against those criteria. Therefore, the "acceptance criteria" are implied by the equivalence demonstration, and performance is reported relative to the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Equivalence to Predicate) | Reported S.E.A.L. Hemostatic Wound Spray Performance |
|---|---|
| Hemostatic Efficacy | |
| Non-inferiority to predicate (CELOX) in stopping bleeding | In vitro coagulation test (viscometry) of porcine blood: Equivalent to CELOX. Rat liver model: Non-inferior to CELOX. Standard swine hemorrhage model: High efficacy to achieve hemostasis, with no statistically significant differences in bleeding time, blood loss, and survival time compared to CELOX. |
| Biocompatibility | |
| Non-cytotoxic | Cytotoxicity Study (ISO Elution Method): Severe cell lysis or toxicity (MEM extract). However, the summary states this is attributed to specific chitosan characteristics that limit or prevent fibroblastic growth, not true cytotoxicity for fibroblasts, and the benefit of stopping severe bleeding outweighs this risk for limited contact. |
| Non-irritating | ISO Intracutaneous Irritation Study: Non-irritating (saline extract). Irritating (sesame oil extract). The summary attributes the sesame oil extract irritation to particles/agglomerates increasing mechanical irritation, and not a risk for the intended use with limited contact. |
| Non-sensitizing | Guinea Pig Maximization Test: Non-sensitizing (saline and sesame oil extracts). |
| No acute systemic toxicity | ISO Acute Systemic Toxicity Study in Mice: No systemic toxicity (saline and sesame oil extracts). |
| Non-pyrogenic | USP Rabbit Pyrogen Study: Non-pyrogenic (saline extract). |
| Safety | |
| No adverse effects (animal studies) | Rat liver model: No adverse effects. Standard swine hemorrhage model: Gross necropsy and histopathology did not show any signs of tissue or organ damage related to device application. Thromboemboli have not developed in surrounding tissues or other areas, and risk of thromboemboli migration to critical structures was ruled out. |
2. Sample Size Used for the Test Set and Data Provenance
The document provides details for animal studies:
- Rat liver model: Used for biological safety and non-inferiority assessment. The specific number of animals is not stated.
- Standard swine hemorrhage model: Used for efficacy assessment. The specific number of animals is not stated.
- Data Provenance: The studies were conducted as "In vivo performance animal studies" to support substantial equivalence. The country of origin is not specified but contract labs were mentioned for biocompatibility tests. The studies are prospective in nature, as they are experiments designed to evaluate the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not mention the use of human experts to establish ground truth for the test set. The efficacy and safety studies were conducted in animal models, likely assessed by researchers and veterinarians. For the biocompatibility tests, the results are based on standardized laboratory protocols (e.g., ISO, USP).
4. Adjudication Method for the Test Set
Not applicable. The "test set" here refers to animal subjects used in experimental studies, not a human reader study with adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The device is a hemostatic wound spray, not an imaging device or diagnostic tool that would typically involve human readers interpreting results.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical product (hemostatic spray), not an algorithm or AI system. The performance evaluated is the standalone performance of the physical device.
7. The Type of Ground Truth Used
- For Hemostatic Efficacy: Ground truth was established through direct observation and quantitative measurements in live animal models (e.g., bleeding time, blood loss, survival time, gross necropsy, histopathology).
- For Biocompatibility: Ground truth was established against international standards and validated laboratory methods (e.g., ISO 10993-1 for cytotoxicity, irritation, sensitization, acute systemic toxicity; USP Rabbit Pyrogen Study).
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
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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
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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
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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
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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
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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
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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
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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 | ReferencePredicative Device |
| Trade name | S.E.A.L.Hemostatic WoundSpray | CELOX TopicalHemostatic Granules | Seal-On ™Hemostatic PowderSpray |
| CompanyName | BC3 Technologies,Inc. | MEDTRADEPRODUCTSLIMITED | Alltracel PharmaLtd. |
| 510(k) # | K210751 | K061079 | K010933 |
| Product Code | FRO | FRO | FRO |
| Hemostaticingredient | Chitosan, amaterial consistingof cellulosicpolymer, poly-N-acetyl-glucosamine | Chitosan polymer,poly-N-acetyl-glucosamine, in drygranules form | Oxidized cellulose |
| Auxiliarymaterials | Acid andpropellant | Acid and undisclosedmaterials | Propellant andundisclosedmaterials |
| Physicalcomposition | Powder in anaerosol form | Granules | Powder in anaerosol form |
| Particleshape andsize | Irregular, less than1 mm | Not disclosed | Irregular, less than1 mm |
DEVICE COMPARISON CHART
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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))
| IndicationsFor Use | Prescription Use:S.E.A.L.Hemostatic WoundSpray is intendedto be used toachievehemostasis inemergencysituations for thetemporary controlof severe topicalbleeding.OTC:S.E.A.L.Hemostatic WoundSpray is indicatedfor the localmanagement ofbleeding such aslacerations, minorcuts andabrasions. | Intended (Rx) to beused to achievehemostasis inemergency situationsfor the temporarycontrol of severetopical bleeding.CELOX TopicalHemostatic GranulesOTC are indicated forthe localmanagement ofbleeding such aslacerations, minorcuts and abrasions. | Seal-On™Hemostatic PowderSpray is indicatedfor OTC use in thetopical control ofbleeding from minorcuts and abrasionsof the skin surface. |
|---|---|---|---|
| PackagingSterilizationMethod | Aluminum canGamma irradiation | Aluminum pouchGamma irradiation | Aluminum canGamma 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.
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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.
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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 (< 24 h), and the testing included cytotoxicity, irritation, sensitization, acute systemic toxicity and material-mediated pyrogenicity.
The results of the biocompatibility testing are summarized in the following table:
| Test | Results |
|---|---|
| ------ | --------- |
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Image /page/8/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 across the heart. To the right of the heart, the text "BC3" is written in red, with the word "Technologies" in a smaller font below it. The logo appears to represent a technology company in the healthcare sector.
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))
| Cytotoxicity Study Using the ISOElution Method | Severe cell lysis or toxicity (MEMextract). |
|---|---|
| ISO Intracutaneous Irritation Study –Extract | Non-irritating (saline extract). Irritating(sesame oil extract). |
| Guinea Pig Maximization Test (ISO) | Non-sensitizing (saline and sesame oilextracts). |
| ISO Acute Systemic Toxicity Study inMice | No systemic toxicity (saline andsesame oil extracts). |
| USP Rabbit Pyrogen Study, MaterialMediated | Non-pyrogenic (saline extract). |
The biocompatibility testing confirmed that S.E.A.L. is non-irritating (saline extract), non-sensitizing, has no systemic toxicity and is non-pyrogenic. The cytotoxicity testing showed severe cell lysis or toxicity, and the sesame oil extract (in contrast to saline) caused erythema and edema in the intracutaneous irritation testing.
The results of the cytotoxicity testing conducted at the contract labs by incubating fibroblast cells in the presence of extracts of S.E.A.L. chitosan can be attributed to the specific characteristics of chitosan which is not cytotoxic for fibroblasts but limits or prevents the fibroblastic growth. We conclude that the benefit of the efficient stop of severe bleeding significantly outweighs the potential risk of a reduced fibroblast proliferation for the limited time of contact with breached/compromised skin.
The erythema and edema observed after injection of sesame oil extracts of S.E.A.L. chitosan into the back of rabbits can be attributed to the presence of particles and agglomerates of large amount and size which will increase the risk of mechanical irritation in skin tissue. No such observations of erythema and edema were made with saline extracts in which the amount and size of particles is small. We conclude that the result of the irritation test can be attributed to the test conditions and interaction with the test medium and does not represent a risk for the limited time of use of S.E.A.L. as indicated.
None of the saline or sesame oil extracts tested for sensitization and acute systemic toxicity showed any signs of intolerance or toxicity, and we conclude that in the overall benefit/risk assessment S.E.A.L. can be considered as safe and as efficient as its predicate device as a material to stop severe bleeding in limited contact with the breached/compromised skin.
VIII. CONCLUSIONS
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The S.E.A.L. Hemostatic Wound Spray, to be distributed by BC3 TECHNOLOGIES INC, is substantially equivalent in design and function to CELOX Topical Hemostatic Granules (K061079), manufactured by MedTrade Products and Seal-On™ Hemostatic Powder Spray (K010933), manufactured by Alltracel Pharma Ltd. The subject device has the same intended use, material composition, and similar characteristics and functional properties as the predicate devices. Moreover, documentation supplied in this submission demonstrates that any differences in their technological characteristics or materials do not raise any new questions of safety or effectiveness, and that the non-clinical data for the device supports the safety of the device.
Wayne L. Grube Jr. CEO 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
N/A