(155 days)
Not Found
No
The device description and intended use are for a topical hemostasis pad made of calcium alginate. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is used to promote the rapid control of bleeding and provide hemostasis for various types of wounds, which aligns with the definition of a therapeutic device.
No
The device is described as a topical hemostasis pad used to promote the rapid control of bleeding and provide hemostasis. It does not mention any function related to diagnosing a condition or disease.
No
The device description clearly states that CalgaeSeal is calcium alginate packaged in a pouch and used as a topical hemostasis pad, indicating it is a physical material, not software.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of CalgaeSeal is to promote hemostasis (stop bleeding) on the skin surface for various types of wounds and procedures. This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The device is a topical hemostasis pad made of calcium alginate. Its function is to physically interact with blood to promote clotting. This is a physical/mechanical action, not a diagnostic test performed on a sample taken from the body.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze a sample (like blood, urine, or tissue) to provide information about a patient's health status, disease, or condition. IVDs are designed to perform such analyses.
In summary, CalgaeSeal is a medical device used for wound management and hemostasis, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
CalgaeSeal is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incisions. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis and in patients on anticoagulation therapy. May be used in conjunction with a facility approved, post-hemostasis site dressing.
Product codes (comma separated list FDA assigned to the subject device)
QSY, FRO
Device Description
CalgaeSeal is calcium alginate packaged in a Tyvek and Mylar pouch and sterilized by gamma radiation to a 10°-6 SAL and used as a topical hemostasis pad.
CalgaeSeal can be used alone as a wound dressing. It may be used in conjunction with manual pressure or FDA cleared mechanical pressure devices to provide rapid control of bleeding and hemostasis at the skin surface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin surface
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)
Testing by DeRoyal in 510 (k) K914779:
Biomaterials - skin irritation: ASTM F719, Pass
Contact Allergens: ASTM F720, Pass
Intracutaneous Injecting Extracts: ASTM F749, Pass
Systemic Injections of Extracts: ASTM F750, Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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 two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
July 28, 2023
BZ Medical Inc. c/o Byron Zahler President 6611 SW Burlingame Avenue Portland, Oregon 97239
Re: K101097 Trade/Device Name: CalgaeSeal Regulatory Class: Unclassified Product Code: QSY
Dear Byron Zahler:
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 September 22, 2010. 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
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
BZ Medical, Inc. % Mr. Byron Zahler President 6611 SW Burlingame Avenue Portland, Oregon 97239
Re: K101097
Trade/Device Name: CalgaeSeal Regulatory Class: Unclassified Product Code: FRO Dated: September 10, 2010 Received: September 14, 2010
Dear Mr. Zahler:
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 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
SEP 22 2010
2
Page 2 - Mr. Byron Zahler
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.htm.
Sincerely yours,
Sincerely yours,
for Ole Dominiompt
Mark N. Melkerson Dep Dir
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K101097
Device Name: CalgaeSeal
SEP 2 2 2010
Indications for Use:
CalgaeSeal is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incisions. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis and in patients on anticoagulation therapy. May be used in conjunction with a facility approved, post-hemostasis site dressing.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
Page _ of _
co/og.
4
510(k) SUMMARY of Safety and Effectiveness (Pursuant to 21 CFR 807.92) September 10, 2010
SEP 22 2010
| | Submitted By: | BZ Medical Inc.
6611 SW Burlingame Ave
Portland, OR 97239 | | |
|---|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|--|--|
| | Contact Person: | Byron Zahler
President
503 244-7348 | | |
| 2 | Proprietary Name:
Common Name:
Classification Name: | CalgaeSeal
Topical Hemostasis Pad
Dressing, Wound, Drug | | |
| | Predicate Devices:
a. DeRoyal Industries
b. TZ Medical
c. Evolution Medical Tech. | Kalginate
K914779
K040208
Neptune
Algiseal Pad
K091194 | | |
4 Device Description:
CalgaeSeal is calcium alginate packaged in a Tyvek and Mylar pouch and sterilized by gamma radiation to a 10°-6 SAL and used as a topical hemostasis pad.
CalgaeSeal can be used alone as a wound dressing. It may be used in conjunction with manual pressure or FDA cleared mechanical pressure devices to provide rapid control of bleeding and hemostasis at the skin surface.
5 Device Intended Use:
CalgaeSeal is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incisions. It can be used to achieve the skin surface for arterial/venous hemostasis at catheterization/tubes, needle puncture, hemodialysis and in patients on anticoagulation therapy. May be used in conjunction with a facility approved, post-hemostasis site dressing.
Technical Characteristics Summary: б
CalgaeSeal has the same technological characteristics as the predicates devices. Following is a summary of the technological characteristics of CalgaeSeal in comparison to those of the predicate devices.
5
| Technical Characteristics | Predicated Devices
Kalginate - K914779
Neptune - K040208
Algiseal Pad - K091194 | CalgaeSeal
- K101097 |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Material | Calcium Alginate | Identical |
| Chemical Composition | Mannuronate and Guluronate residues | Identical |
| Design | A sterile, nonwoven fabric pad made of heavy,
dense denier calcium alginate fibers. | Identical |
| Function (A); | Absorbent - In moist wound, calcium Alginate
changes to thick fibrous gel that provides a moist
environment conductive to granulation tissue
formation and epithelial growth. | Identical |
| Function (B): | Hemostasis - Concentrates coagulation
components by absorbing the fluid components
of blood. | Identical |
| Testing by DeRoyal in
510 (k) K914779: | Standard
| Performance |
| Biomaterials - skin irritation | ASTM F719 | Pass
Identical |
| Contact Allergens | ASTM F720 | Pass
Identical |
| Intracutaneous Injecting
Extracts | ASTM F749 | Pass
Identical |
| Systemic Injections of
Extracts | ASTM F750 | Pass
Identical |
.
1000 - 1000
!