(102 days)
No
The device description and intended use focus on physical components (pads and bands) for applying pressure and promoting hemostasis. There is no mention of any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device (Neptune Pad, Neptune Comfort-Band, and Comfort-Band) is intended to promote the rapid control of bleeding and provide hemostasis for various conditions, which are therapeutic actions.
No
These devices are designed to control bleeding and provide hemostasis, which is a therapeutic function, not a diagnostic one. They do not analyze or interpret physiological data to identify a medical condition.
No
The device description clearly outlines physical components (pads and bands) used for applying pressure and promoting hemostasis, indicating it is a hardware-based medical device, not software-only.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro) to provide information about a person's health.
- Device Function: The descriptions of the Neptune Pad and Comfort-Band clearly indicate they are used on the body surface to control bleeding and provide hemostasis. They are physical devices applied externally.
- Intended Use: The intended uses described are for managing bleeding from wounds, access sites, and surgical incisions, which are all external applications.
- Device Description: The descriptions detail physical pads and bands used for pressure and wound dressing, not for analyzing biological samples.
The device's function and intended use are entirely focused on external wound management and hemostasis, which falls under the category of medical devices used in vivo (on or in the body), not in vitro (outside the body for diagnostic testing).
N/A
Intended Use / Indications for Use
Neptune Pad (calcium alginate pad alone): Neptune 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 and in patients on anticoagulation therapy.
Neptune Comfort-Band (Pressure Band with calcium alginate pad): Neptune Comfort-Band is used to provide pressure and promote the rapid control of bleeding and promote hemostasis following needle puncture, arterial/venous catheterization and access sites, including patients on anticoagulation therapy, and following hemodialysis.
Comfort-Band (Pressure Band alone): Comfort-Band is used to provide pressure and promote the rapid control of bleeding and hemostasis following needle puncture, arterial/venous catheterization and access sites, including patients on anticoagulation therapy, and following hemodialysis. It may be used alone, with Neptune Pad, with sterile gauze or other sterile wound dressings.
Product codes (comma separated list FDA assigned to the subject device)
QSY, FRO
Device Description
Neptune Pad - Varying size, 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 hemostasisat the skin surface.
Neptune Comfort-Band - The Comfort-Band is packaged with a Neptune Pad, and sterilized. It is strapped around the arm (hemodialysis graft, or radial/brachial arteries) to provide pressure for rapid control of bleeding and hemostasis.
Comfort-Band - The Comfort-Band is provided sterile or non-sterile, single use only. Non-sterile Comfort-Bands are provided with cleaning and high level disinfectant instructions) The Sterile Comfort-Band is packaged alone and EtO sterilized. The Comfort-Bands may be used with or without a dressing. The device is strapped around the arm (hemodialysis graft, or radial/brachial arteries) to provide rapid pressure control of bleeding and hemostasis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin surface, arm (hemodialysis graft, or radial/brachial arteries)
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)
The TZ Medical Neptune products have been tested and are considered safe and effective. With the exception of the Comfort-Band material and an adhesive interface between the Comfort-Band and calcium alginate pad, all other products and processes are identical to products with current 510(k)s K920614, and K941176). Testing and support data are on file. Data demonstrates there are no new risks associated with the product.
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.
K941176, K920614, K021062, K984177
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 the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is a stylized depiction of a human figure, while the FDA logo features the agency's acronym in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. The logos are placed side by side.
June 11, 2023
TZ Medical, Inc. Madalyn C. Duncan Regulatory Affairs/Quality Assurance Specialist 7272 S.W. Durham Road, #800 Portland, Oregon 97724
Re: K040208 Trade/Device Name: Neptune Products Regulatory Class: Unclassified Product Code: QSY
Dear Madalyn C. Duncan:
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 11, 2004. 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.
Image /page/0/Picture/7 description: This image shows the closing of a letter, including the name and title of the sender. The sender is Julie A. Morabito, Ph.D., who is the Assistant Director of DHT4B: Division of Infection Control and Plastic Surgery Devices. The letter also includes the sender's office, which is OHT4: Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality, and 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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Public Health Service
MAY 11 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Madalyn C. Duncan Regulatory Affairs/Quality Assurance TZ Medical, Inc. 7272 S.W. Durham Road, #800 Portland, Oregon 97724
Re: K040208 Trade/Device Name: Neptune Products Regulatory Class: Unclassified Product Code: FRO Dated: April 22, 2004 Received: April 27, 2004
Dear Ms. Duncan:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave revioused your becermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conniner of the to may 2011 accordance with the provisions of the Federal Food, Drug, de neces mat have been require approval of a premarket approval application (PMA). and Cosmetic (110-) that to the vice, subject to the general controls provisions of the Act. The r ou may, diererore, mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can may be factor to 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 cquivalence determination does not mean i tease oe activised that i bring in that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of R rate 677), ideeing (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Madalyn C. Duncan
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and my Jorne FDA finding of substantial equivalence of your device to a legally prematics noticated on " results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire spotitio arroviance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miormational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K040208_
Device Name: Neptune Products
Indications For Use:
Neptune Pad (calcium alginate pad alone): Neptune 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 and in patients on anticoagulation therapy.
Neptune Comfort-Band (Pressure Band with calcium alginate pad): Neptune Comfort-Band is used to provide pressure and promote the rapid control of bleeding and promote hemostasis following needle puncture, arterial/venous catheterization and access sites, including patients on anticoagulation therapy, and following hemodialysis.
Comfort-Band (Pressure Band alone): Comfort-Band is used to provide pressure and promote the rapid control of bleeding and hemostasis following needle puncture, arterial/venous catheterization and access sites, including patients on anticoagulation therapy, and following hemodialysis. It may be used alone, with Neptune Pad, with sterile gauze or other sterile wound dressings.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) r
hovrst
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
4
K040208 page 1/2
MAY 11 2004
510(k) SUMMARY of Safety and Effectiveness
(Persuant to 21 CFR 807.92)
GENERAL l.
| A. | Submitted By: | TZ Medical Inc.
7272 S.W. Durham Road #800
Portland, Oregon 97724 |
|----|----------------------|--------------------------------------------------------------------------|
| B. | Contact Person | Madalyn C. Duncan
Regulatory Affairs/ Quality Assurance
Specialist |
| C. | Proprietary Name: | Neptune Pad
Neptune Comfort-Band
Comfort-Band |
| D. | Classification Name: | Unknown |
| E. | Classification: | Unclassified |
II. DEVICE INFORMATION SUMMARY
A. Predicate Device
| Kalginate by DeRoyal | (K941176) |
|---|---|
| HemoBand (originally manufactured for | |
| Innovations for Access by TZ Medical) | (K920614) |
| Chito-Seal by Perclose | (K021062) |
| Syvek Patch by Marine Polymer | |
| Technology | (K984177) |
். Device Description
Neptune Pad - Varying size, 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 hemostasisat the skin surface.
Neptune Comfort-Band - The Comfort-Band is packaged with a Neptune Pad, and sterilized. It is strapped around the arm (hemodialysis graft, or radial/brachial arteries) to provide pressure for rapid control of bleeding and hemostasis.
Comfort-Band - The Comfort-Band is provided sterile or non-sterile, single use only. Non-sterile Comfort-Bands are provided with cleaning and high level disinfectant instructions) The Sterile Comfort-Band is packaged
5
K040208 Age 1/2
alone and EtO sterilized. The Comfort-Bands may be used with or without a dressing. The device is strapped around the arm (hemodialysis graft, or radial/brachial arteries) to provide rapid pressure control of bleeding and hemostasis.
B. Device Intended Use
Neptune products are used to promote the rapid control of bleeding and hemostasis for wounds, the skin surface at arterial/vascular sites and in patients on anticoagulation therapy.
SUBSTANTIAL EQUIVQALENCE TESTING SUMMARY lll.
The TZ Medical Neptune products have been tested and are considered safe and effective. With the exception of the Comfort-Band material and an adhesive interface between the Comfort-Band and calcium alginate pad, all other products and processes are identical to products with current 510(k)s K920614, and K941176). Testing and support data are on file. Data demonstrates there are no new risks associated with the product.