NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND

K040208 · Tz Medical, Inc. · QSY · May 11, 2004 · SU

Device Facts

• Record ID: K040208
• Device Name: NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND
• Applicant: Tz Medical, Inc.
• Product Code: QSY · SU
• Decision Date: May 11, 2004
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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.

Device Story

Neptune Products consist of calcium alginate pads and pressure bands (Comfort-Band) used for hemostasis. Neptune Pad acts as a topical wound dressing; Neptune Comfort-Band combines the pad with a strap for mechanical pressure; Comfort-Band provides mechanical pressure alone. Used in clinical settings for vascular access sites, hemodialysis, and post-surgical wounds. Operated by healthcare professionals to secure access sites and control bleeding. Mechanical pressure facilitates rapid hemostasis; calcium alginate promotes clotting. Benefits include reduced bleeding time and improved site management for patients, including those on anticoagulation therapy.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Neptune Pad: calcium alginate. Comfort-Band: strap/pressure band. Sterilization: EtO (sterile versions). Single-use. Mechanical pressure application. No software or electronic components.

Indications for Use

Indicated for patients requiring hemostasis at skin surface for lacerations, abrasions, surgical incisions, needle punctures, and arterial/venous catheterization/access sites, including hemodialysis patients and those on anticoagulation therapy.

Regulatory Classification

Identification

To temporarily control bleeding and cover external wounds.

Predicate Devices

• Kalginate by DeRoyal (K941176)
• HemoBand (K920614)
• Chito-Seal by Perclose (K021062)
• Syvek Patch by Marine Polymer Technology (K984177)

Submission Summary (Full Text)

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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, [e-mail].

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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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 [phone]. 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 [phone] or [phone] 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.<br>7272 S.W. Durham Road #800<br>Portland, Oregon 97724 |
|----|----------------------|--------------------------------------------------------------------------|
| B. | Contact Person | Madalyn C. Duncan<br>Regulatory Affairs/ Quality Assurance<br>Specialist |
| C. | Proprietary Name: | Neptune Pad<br>Neptune Comfort-Band<br>Comfort-Band |
| D. | Classification Name: | Unknown |
| E. | Classification: | Unclassified |

#### II. DEVICE INFORMATION SUMMARY

#### A. Predicate Device

| Kalginate by DeRoyal | (K941176) |
|--------------------------------------------------------------------------------|-----------|
| HemoBand (originally manufactured for<br>Innovations for Access by TZ Medical) | (K920614) |
| Chito-Seal by Perclose | (K021062) |
| Syvek Patch by Marine Polymer<br>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

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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