(25 days)
No
The 510(k) summary describes a calcium alginate pad for hemostasis and wound dressing. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the material and its physical properties for controlling bleeding.
No
This device is identified as functioning in a manner similar to wound dressings and hemostatic pads, which are generally considered Class I or II devices intended to aid in the control of bleeding and wound care, rather than providing a therapeutic effect like curing a disease or restoring a function.
No
Explanation: The Algiseal Pad is described as a product used to control bleeding and provide hemostasis. Its function is to treat a condition (bleeding), not to diagnose it.
No
The device description clearly indicates a physical pad made of calcium alginate, which is a hardware component. The intended use also describes a physical application to the skin surface.
Based on the provided information, the Algiseal Pad is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Algiseal Pad's Function: The Algiseal Pad is a topical device applied directly to the skin surface to control bleeding and promote hemostasis. It interacts directly with the wound or puncture site on the body.
- Intended Use: The intended use clearly describes its application for controlling bleeding on the skin surface, not for analyzing samples taken from the body.
- Device Description: The description reinforces its use as a wound dressing and hemostatic agent applied externally.
Therefore, the Algiseal Pad falls under the category of a topical hemostatic device or wound dressing, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Algiseal Pad (calcium alginate pad alone and pad with permeable adhesive backing): Algiseal Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incision. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis patients and in patients on anticoagulation therapy. May be used in conjunction with a facility approved, posthemostasis site dressing.
Product codes
QSY
Device Description
Algiseal Pad - (Varying size, with and without permeable adhesive backing, packaged sterile) Pads may be used alone as a wound dressing. The Pad may also be used with manual pressure or FDA cleared mechanical pressure devices to provide rapid control of bleeding and hemostasis at the skin surface. May be used in conjunction with a facility approved, post-hemostasis site dressing.
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
The Evolution Medical Technologies LLC Algiseal products have been tested and are considered safe and effective. Testing and support data are on file to demonstrate substantial equivalence to predicate devices. Data demonstrates there are no new risks associated with the product.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and 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.
Evolution Medical Technologies, LLC c/o John Manning President 3439 NE Sandy Boulevard, Suite 142 Portland, Oregon 97232
July 28, 2023
Re: K091194
Trade/Device Name: Algiseal Pad (Various sizes, with and without permeable adhesive backing, sterile, single use only) Regulatory Class: Unclassified Product Code: QSY
Dear John Manning:
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 May 18, 2009. 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 and Human Services. The logo features a stylized eagle with three overlapping wing shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
MAY 18 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Evolution Medical Technologies, LLC % Mr. John Manning President 3439 NE Sandy Boulevard, Suite 142 Portland, Oregon 97232
Re: K091194
Trade/Device Name: Algiseal Pad (Various sizes, with and without permeable adhesive backing, sterile, single use only)
Regulatory Class: Unclassified Product Code: FRO Dated: April 21, 2009 Received: April 23, 2009
Dear Mr. Manning:
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 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 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at
2
Page 2 - Mr. John Manning
(240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
for Dork D.r
Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number: K091194
Device Name:
Algiseal Pad (Various sizes, with and without permeable adhesive backing, sterile, single use only)
Indications For Use:
Algiseal Pad (calcium alginate pad alone and pad with permeable adhesive backing): Algiseal Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incision. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis patients and in patients on anticoagulation therapy. May be used in conjunction with a facility approved, posthemostasis site dressing.
Prescription Use X
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Keane for MXM
Surgical. Orthopedic. and Restorative De
510(k) Number K091194
ਹੈ-ਰੇ
4
Page 1 of 1
EV MED TECH LLC
510(k) SUMMARY of Safety and Effectiveness
(Pursuant to 21 CFR 807.92)
| April 21, 2009 | |
|---|---|
| -- | ---------------- |
| MAY 18 2009 | |
|---|---|
| -- | ------------- |
I. GENERAL
| A. Submitted By: | Evolution Medical Technologies LLC. |
|---|---|
| 3439 NE Sandy Blvd. | |
| Suite # 142 | |
| Portland, Oregon 97232 | |
| B. Contact Person | John Manning |
| President | |
| C. Proprietary Name: | Algiseal Pad |
| D. Classification Name: | Unknown |
| E. Classification: | Unclassified |
II. DEVICE INFORMATION SUMMARY
| A. Predicate Device | |
|---|---|
| --------------------- | -- |
FDA CDRH DMC
APR 23 2009
Received
K-7
Kalginate by DeRoyal
Neptune Pad by TZ Medical
by 12 Medical
B. Device Intended Use
Algiseal products are used to promote the rapid control of bleeding and hemostasis for wounds, at the skin surface for arterial/vascular sites and in patients on anticoagulation therapy. May also be used in conjunction with a facility approved, post-hemostasis site dressing.
C. Device Description
.
Algiseal Pad - (Varying size, with and without permeable adhesive backing, packaged sterile) Pads may be used alone as a wound dressing. The Pad may also be used with manual pressure or FDA cleared mechanical pressure devices to provide rapid control of bleeding and hemostasis at the skin surface. May be used in conjunction with a facility approved, post-hemostasis site dressing.
SUBSTANTIAL EQUIVALENCE TESTING SUMMARY lll.
The Evolution Medical Technologies LLC Algiseal products have been tested and are considered safe and effective. Testing and support data are on file to demonstrate substantial equivalence to predicate devices. Data demonstrates there are no new risks associated with the product.
(K040208)