Hemoblock_S (Prescription); Hemoblock_S (OTC)

• K Number: K232216
• Device Name: Hemoblock_S (Prescription); Hemoblock_S (OTC)
• Manufacturer: Incore Co., Ltd.
• Date Cleared: 2024-04-19 ( 268 days)
• Product Code: QSY OSY
• Regulation Number: N/A

Intended Use

Hemoblock S (Prescription): For use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions and lacerations Hemoblock S (OTC): To control bleeding of minor lacerations, minor cuts and minor abrasions

Device Description

The Hemoblock_S (Hemoblock_S (Prescription Use) and Hemoblock_S (OTC Use)) for being placed on the U.S.A Market is single use, hemostatic dressing made of Chitosan and Cotton. This device is called to Hemoblock Gauze on the Republic of Korea Market. Chitosan is a naturally occurring polysaccharide usually derived from shellfish, and its hemostatic properties are widely recognized in the biomedical field. When applied directly on a wound with firm pressure, the Hemoblock_S acts as a mechanical barrier against bleeding by turning into a gel-like condition to absorb the blood and assist in temporarily controlling moderate to severe bleeding. The Hemoblock_S is provided in two different types to accommodate a variety of treatment regions, according to being based on the whether strap yan which is consisted with Nylon and handle for remove a device into any wound, with following; - Gauze(N) Type: There is not strap yarn part on the Hemoblock_S - Gauze(S) Type: There is strap yarn part on the Hemoblock_S The Hemoblock_S is individually packaged in a foil pouch and is Irradiation sterilized in accordance with ISO 11137 Series.

Predicate Devices

K133121

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the material properties (Chitosan, Cotton) and mechanical action of the dressing. There is no mention of AI, ML, image processing, or data-driven analysis for diagnosis or treatment.

Therapeutic

Yes.
Explanation: The device is intended to control bleeding and manage external abrasions and lacerations, which are therapeutic actions.

Diagnostic

No

The device is a hemostatic dressing intended to control bleeding and manage external wounds; it does not diagnose any condition or disease.

SaMD (Software as a Medical Device)

No

The device is described as a physical hemostatic dressing made of Chitosan and Cotton, indicating it is a hardware device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Hemoblock S device is not an In Vitro Diagnostic (IVD).

Here's why:

• Intended Use: The intended use clearly states it's for controlling bleeding and managing external wounds. This is a direct therapeutic application on the body.
• Device Description: The description details a physical dressing made of Chitosan and Cotton that is applied externally to a wound. It describes a mechanical action (forming a gel-like condition) to absorb blood and control bleeding.
• Lack of In Vitro Activity: There is no mention of the device being used to test samples of blood, tissue, or other bodily fluids outside of the body to diagnose a condition or provide information about a patient's health state. IVDs are used for testing in vitro (in glass, or outside the body).
• Performance Studies: The performance studies focus on biocompatibility, sterilization, shelf life, physical properties, and in vivo hemostatic testing (on live animals). These are typical tests for a medical device intended for direct application to the body, not for an IVD.
• Predicate Device: The predicate device (Chito-SAM TM 100/Active) is also a hemostatic dressing, further supporting that this device falls under the category of a wound dressing or hemostatic agent, not an IVD.

In summary, the Hemoblock S is a medical device intended for external application to control bleeding, which is a therapeutic function performed in vivo (on the body), not an in vitro diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Hemoblock S (Prescription): For use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions and lacerations
Hemoblock S (OTC): To control bleeding of minor lacerations, minor cuts and minor abrasions

Product codes (comma separated list FDA assigned to the subject device)

QSY

Device Description

The Hemoblock_S (Hemoblock_S (Prescription Use) and Hemoblock_S (OTC Use)) for being placed on the U.S.A Market is single use, hemostatic dressing made of Chitosan and Cotton. This device is called to Hemoblock Gauze on the Republic of Korea Market.

Chitosan is a naturally occurring polysaccharide usually derived from shellfish, and its hemostatic properties are widely recognized in the biomedical field. When applied directly on a wound with firm pressure, the Hemoblock_S acts as a mechanical barrier against bleeding by turning into a gel-like condition to absorb the blood and assist in temporarily controlling moderate to severe bleeding. The Hemoblock_S is provided in two different types to accommodate a variety of treatment regions, according to being based on the whether strap yan which is consisted with Nylon and handle for remove a device into any wound, with following;

• . Gauze(N) Type: There is not strap yarn part on the Hemoblock_S
• . Gauze(S) Type: There is strap yarn part on the Hemoblock_S

The Hemoblock_S is individually packaged in a foil pouch and is Irradiation sterilized in accordance with ISO 11137 Series.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

External 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)

Non-Clinical Testing:

• Biocompatibility Test: Performed according to ISO 10993-1 and FDA guidance ("Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process") for surface devices contacting breached or compromised surfaces for a limited duration (≤ 24h). Test items included Cytotoxicity Test, Sensitization, Irritation or intracutaneous reactivity, Material mediated pyrogenicity, and Acute systemic toxicity.
• Sterilization and Shelf life: Sterilized using Irradiation (E-beam) to a sterility assurance level (SAL) of 10-6, in compliance with ISO 11137-1, ISO 11137-2, and ISO 11137-3. Packaging subjected to sterile barrier testing to validate a shelf life of five (5) years as per ISO and ASTM standards. Stability and effectiveness of packaging confirmed by real-time stability studies and accelerated aging test (ASTM F-1980), Package seal strength per ASTM F88/F88M, Dye migration test as per ASTM F1929, and Sterility test as per ISO 11737-2.
• Performance Test - Non clinical: Physical performance tests met acceptance criteria including Appearance, Dimension, Tensile Strength (ISO 9073-18), Absorption (EN 13726-1), Nylon Tensile Strength (ASTM D2256), X-ray impermeableness, Virus Inactivation Validation Report, and In Vitro Blood Clotting Test.
• Performance Test - Animal Test: An in vivo hemostatic testing study was conducted using 12 female New Zealand white rabbits.

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.

K133121

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

Regulation Number and Section

N/A

Summary

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 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.

April 19, 2024

Incore Co., Ltd. % Milly An Consultant KMC, Inc. Room no. 1709, 123, Digital-ro 26-gil, Guro-gu Seoul, 08390 Korea, South

Re: K232216

Trade/Device Name: Hemoblock S (Prescription); Hemoblock S (OTC) Regulatory Class: Unclassified Product Code: QSY Dated: March 18, 2024 Received: March 19, 2024

Dear Milly An:

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 (the 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 available 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.

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Page

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Mustafa A. Mazher -S

for Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K232216

Device Name Hemoblock S (Prescription); Hemoblock S (OTC)

Indications for Use (Describe)

Hemoblock S (Prescription): For use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions and lacerations

Hemoblock S (OTC): To control bleeding of minor lacerations, minor cuts and minor abrasions

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

1. INFORMATION

1.1 Submitter Information

• 트 Submitter Name: INCORE Co., Ltd.
• Address
  • : 11, Hyeoksin-daero 78-gil, Dong-gu, Daegu, Republic of Korea
• Telephone Number: [phone] . 트 Fax: [phone]

1.2 Official Correspondent Person

• . Name: Milly (Consultant / KMC, Inc.)
• 트 Address: Rm. No. 1709, 123, Digital-ro 26-gil, Guro-gu, 08390, Republic of Korea

י

Fax: [phone]

• 트 Telephone Number: [phone]
• . E-mail: [e-mail]
• 1.3 Date prepared: April 16, 2024

2. DEVICE INFORMATION

• 2.1 Trade Name / Proprietary Name: Hemoblock_S (Prescription), Hemoblock_S (OTC)
• 2.2 Common Name: Non-absorbable Hemostatic Dressing
• 2.3 Product Code: OSY
• 2.4 Device Class: Unclassified
• 2.5 Panel: General & Plastic Surgery

3. PREDICATE DEVICE

Manufacturer	SAM Medical Products
Device Name (Trade Name)	Chito-SAM TM 100(Prescription use)
Chito-SAM TM Active (Over-the-counter Use)
510(k) Number	K133121

4. Device Description

The Hemoblock_S (Hemoblock_S (Prescription Use) and Hemoblock_S (OTC Use)) for being placed on the U.S.A Market is single use, hemostatic dressing made of Chitosan and Cotton. This device is called to Hemoblock Gauze on the Republic of Korea Market.

Chitosan is a naturally occurring polysaccharide usually derived from shellfish, and its hemostatic properties are widely recognized in the biomedical field. When applied directly on a wound with firm pressure, the Hemoblock_S acts as a mechanical barrier against bleeding by turning into a gel-like

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condition to absorb the blood and assist in temporarily controlling moderate to severe bleeding. The Hemoblock_S is provided in two different types to accommodate a variety of treatment regions, according to being based on the whether strap yan which is consisted with Nylon and handle for remove a device into any wound, with following;

• . Gauze(N) Type: There is not strap yarn part on the Hemoblock_S
• . Gauze(S) Type: There is strap yarn part on the Hemoblock_S

The Hemoblock_S is individually packaged in a foil pouch and is Irradiation sterilized in accordance with ISO 11137 Series.

| Type | Thickness
(Unit: mm) | Wide x Length (Unit: cm) | Stran yan length
(Unit: cm) |
|------------------|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Gauze(N)
Type | 0.4 | 7.5 x 10, 7.5 x 20
7.5 x 100, 7.5 x 200, 7.5 x 300, 7.5 x 370
5.0 x 5.0, 5.0 x 7.5, 5.0 x 40
3.5 x 20
12 x 300
10 x 10 | N/A |
| Gauze(S)
Type | 1.5 | 9 x 36
18 x 36 | 18 |

Hemoblock_S is provided in different size for each types as listed below.

5. INDICATIONS FOR USE

Hemoblock S (Prescription): For use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions and lacerations

Hemoblock_S (OTC): To control bleeding of minor lacerations, minor cuts and minor abrasions.

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6. SUBSTANTIAL EQUIVALENCE

| Descriptive

Information	Subject Device		Predicate Device		Comparison
Manufacturer	INCORE, Co., Ltd.
Hemoblock_S		SAM Medical Products
Chito-SAM		N/A
Product Name	Hemoblock_S
(Prescription
Use)	Hemoblock_S
(OTC Use)	Chito-SAM
100
(Prescription
Use)	Chito-SAM
Active
(OTC Use)	N/A
510(K) Number	K232216		K133121		N/A
Product Code	QSY		QSY		Identical
Indications
for
Use	For use as a
temporary
external
dressing to
control
moderate to
severe
bleeding and
manage
external
abrasions and
lacerations.	To control
bleeding of
minor
lacerations,
minor cuts
and minor
abrasions	For use as a
temporary
external
dressing to
control
moderate to
severe
bleeding and
manage
external
abrasions and
lacerations.	To control
bleeding of
lacerations,
minor cuts and
abrasions	Identical
Anatomical Site	External Wounds		External Wounds		Identical
Material	Gauze: Chitosan
(derived from shellfish)
Bleached cotton
Polypropylene
Barium sulfate
Nylon-6		Gauze: Chitosan
(derived from shellfish)		Different
(Only gauze
part is same)
Physical Form	Sheet Form		Sheet Form		Identical
Size
(W x L)	7.5cm x 10cm
7.5cm x 20cm
7.5cm x 100cm
7.5cm x 200cm
7.5cm x 300cm
7.5cm x 370cm
5.0cm x 5.0cm
5.0cm x 7.5cm
5.0cm x 40cm
3.5cm x 20cm
12cm x 300cm	7.5cm x 10cm
7.5cm x 20cm
7.5cm x 100cm
7.5cm x 200cm
7.5cm x 300cm
7.5cm x 370cm
5.0cm x 5.0cm
5.0cm x 7.5cm
5.0cm x 40cm
3.5cm x 20cm
12cm x 300cm	10cm x 10cm
7.6cm x 122cm
7.6cm x 183cm	7.5cm x 180cm
10cm x10cm	Different
	9cm x 36cm	9cm x 36cm
	18cm x 36cm	18cm x 36cm
Sterilization	Irradiation (E-beam)		Irradiation (Gamma)		Different
Single Use/Re-
use	Single Use		Single Use		Identical
Shelf Life	5 years		3 years		Different
Packaging	Foil Bag		Foil Bag		Identical

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The indications for use for the predicate devices is substantially equivalent to the proposed indications for use for the Hemoblock_S. The technological characteristics of the Hemoblock_S are similar to the predicate devices. Available data, including biocompatibility test, sterilized validation and performance data, support the determination of substantial equivalence. Minor differences, such as size, sterilization method and shelf life, between both devices do not raise any new issues of safety or effectiveness. Thus, the Hemoblock_S is substantially equivalent to the predicate devices

7. Non-Clinical Testing

7.1 Biocompatibility Test

Biocompatibility Testing per ISO 10993-1 and FDA guidance ("Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process") was performed for:

| Nature of body contact | | Contact Duration | Biological Effects
-Test Items |
|------------------------|------------------------------------|--------------------|-----------------------------------------------|
| Category | Contact | | |
| Surface devices | Breached or
compromised surface | A- limited (≤ 24h) | Cytotoxicity Test |
| | | | Sensitization |
| | | | Irritation or
intracutaneous
reactivity |
| | | | Material mediated
pyrogenicity |
| | | | Acute systemic
toxicity |

7.2 Sterilization and Shelf life

Hemoblock_S is supplied sterile in a foil bag. It is sterilized using Irradiation (E-beam) to a sterility assurance level (SAL) of 10-6 . E-beam sterilization was performed in compliance with the ISO 11137-1 and ISO 11137-2 and ISO 11137-3 standards.

Following the E-beam sterilization, the packaging was subjected to sterile barrier testing to validate a shelf life of three (5) years as per ISO and ASTM standards.

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• . The stability and effectiveness of packaging of the sterilized product during the shelf-life period was confirmed by real time stability studies and accelerated aging test, per ASTM F-1980
• Package seal strength per ASTM F88/F88M
• . Dye migration test as per ASTM F1929
• . Sterility test as per ISO 11737-2.

7.3 Performance Test - Non clinical

The physical performance test results all meet the requirements of the acceptance criteria

• . Physical Test
  • Appearance
  • Dimension
  • Tensile Strength (ISO 9073-18)
  • Absorption (EN 13726-1)
  • Nylon Tensile Strength (ASTM D2256)
  • X-ray impermeableness
• Virus Inactivation Validation Report
  • In Vitro Blood Clotting Test

7.4 Performance Test - Animal Test

In the animal study conducted, 12 females New Zealand white rabbit were randomly assigned for in vivo hemostatic testing.

8. Conclusion

.

The Hemoblock_S is substantially equivalent to the predicate device in terms of materials, technological characteristics, indications for use, and performance. No new issues of safety or effectiveness are raised by the Hemoblock S.