← Product Code QSY · K101097 # CALGAESEAL MODEL: CAS (K101097) _Bz Medical, Inc. · QSY · Sep 22, 2010 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K101097 ## Device Facts - **Applicant:** Bz Medical, Inc. - **Product Code:** QSY - **Decision Date:** Sep 22, 2010 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## 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 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. ## Device Story CalgaeSeal is a topical hemostasis pad composed of calcium alginate fibers. It functions by absorbing fluid components of blood to concentrate coagulation factors, promoting rapid bleeding control. In moist wound environments, the material transforms into a thick fibrous gel, supporting granulation and epithelial growth. The device is used in clinical settings or point-of-care environments by healthcare providers; it may be applied alone or in conjunction with manual pressure or mechanical pressure devices. It is intended for use on lacerations, abrasions, surgical incisions, and vascular access sites, including for patients on anticoagulation therapy. The healthcare provider applies the pad to the site to achieve hemostasis, potentially followed by a facility-approved dressing. The device benefits patients by providing a rapid, effective method for managing bleeding at various skin-surface puncture and wound sites. ## Clinical Evidence Bench testing only. Biocompatibility testing performed according to ASTM standards, including skin irritation (ASTM F719), contact allergens (ASTM F720), intracutaneous injection extracts (ASTM F749), and systemic injection extracts (ASTM F750). All tests passed. ## Technological Characteristics Material: Calcium alginate (mannuronate and guluronate residues). Design: Sterile, nonwoven fabric pad of heavy, dense denier calcium alginate fibers. Function: Absorbent gel-forming hemostatic dressing. Sterilization: Gamma radiation (10^-6 SAL). Biocompatibility standards: ASTM F719, ASTM F720, ASTM F749, ASTM F750. ## Regulatory Identification To temporarily control bleeding and cover external wounds. ## Predicate Devices - Kalginate ([K914779](/device/K914779.md)) - Neptune ([K040208](/device/K040208.md)) - Algiseal Pad ([K091194](/device/K091194.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 K101097 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 K101097 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 ! --- **Source:** [https://fda.innolitics.com/device/K101097](https://fda.innolitics.com/device/K101097) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com