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.
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.
The provided text describes the regulatory aspects of TZ Medical's Neptune products (Neptune Pad, Neptune Comfort-Band, and Comfort-Band), including their indications for use and a summary of substantial equivalence testing. However, it does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and a specific study proving the device meets those criteria.
Based on the available information, here's what can be inferred and what is missing:
Missing Information:
The document does not provide:
- A specific table of acceptance criteria with reported device performance metrics (e.g., specific thresholds for hemostasis time, bleeding reduction).
- Details about sample sizes for test sets, data provenance, number or qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth for training sets was established. This is likely because the document is a 510(k) summary, which focuses on substantial equivalence rather than detailed clinical trial results.
Here's an attempt to answer based on the provided text, highlighting the limitations:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the Neptune products. Instead, it makes a general statement about the products being "considered safe and effective" and that "Data demonstrates there are no new risks associated with the product."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not provide any information regarding the sample size, data provenance, or study design (retrospective/prospective) for any test sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
The document does not mention the use of experts to establish a ground truth or their qualifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not describe any adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document does not mention any MRMC studies, nor does it describe an AI component for these devices. The Neptune products are physical hemostatic devices, not AI-driven diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the Neptune products are not algorithms but physical medical devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not specify the type of ground truth used. The statement "Data demonstrates there are no new risks associated with the product" implies some form of testing was conducted to support safety and effectiveness, likely comparing their performance (e.g., hemostasis time) to predicate devices or established benchmarks, but the details are not provided.
8. The sample size for the training set
The document does not specify a training set or its sample size. This is consistent with the nature of the device as a physical product, not an AI model.
9. How the ground truth for the training set was established
Not applicable, as no training set for an AI model is mentioned.
Summary of the Study Mentioned:
The document briefly mentions a "Substantial Equivalence Testing Summary."
- Device Tested: Neptune Pad, Neptune Comfort-Band, and Comfort-Band.
- Methodology (Implied): The devices were tested to demonstrate substantial equivalence to previously cleared predicate devices:
- Key Findings: "The TZ Medical Neptune products have been tested and are considered safe and effective." The submission states that 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)." It concludes that "Data demonstrates there are no new risks associated with the product."
- Limitations: The summary does not provide specific performance data, test protocols, sample sizes, or details on how "safety and effectiveness" were quantified or compared. This summary confirms that some testing was performed to satisfy the regulatory requirement for substantial equivalence, rather than detailing a clinical study with specific acceptance criteria and results.
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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.
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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.
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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
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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_________________________________________________________________________________________________________________________________________________________________
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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 #800Portland, Oregon 97724 |
|---|---|---|
| B. | Contact Person | Madalyn C. DuncanRegulatory Affairs/ Quality AssuranceSpecialist |
| C. | Proprietary Name: | Neptune PadNeptune Comfort-BandComfort-Band |
| D. | Classification Name: | Unknown |
| E. | Classification: | Unclassified |
II. DEVICE INFORMATION SUMMARY
A. Predicate Device
| Kalginate by DeRoyal | (K941176) |
|---|---|
| HemoBand (originally manufactured forInnovations for Access by TZ Medical) | (K920614) |
| Chito-Seal by Perclose | (K021062) |
| Syvek Patch by Marine PolymerTechnology | (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
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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.
Neptune Pad, Neptune Comfort-Band and Comfort-Band
N/A