(90 days)
The Sea-Band Limited "Sea-Band" is indicated for the relief of nausea.
(Nausea is a symptom that may be experienced due to a variety of causes, for example:
- . Travel/Motion
- Pregnancy (Morning Sickness) .
- . Chemotherapy
- Post Operative) .
The "Sea-Band" consists of elasticated wrist band with a plastic button. The button is designed to apply pressure to the P6 or "nei-kuan", acupuncture point.
"Sea-Bands" are designed to be worn on each wrist and are supplied in pairs in a plastic case. The case is contained in an outer cardboard box with instructions for use.
The Sea-Band Ltd , Sea-Band will be available in a variety of different colors and pack types.
I am sorry, but based on the provided text, there is no information about explicit acceptance criteria or a study designed to prove the device meets such criteria in the way you've described for a medical device with performance metrics.
The document is a 510(k) summary for the Sea-Band, focusing on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study against predefined acceptance criteria. This is a common approach for 510(k) submissions, where the safety and effectiveness of a new device are established by showing it is as safe and effective as a legally marketed device.
Here's why I cannot complete the table and answer your questions directly:
- No Explicit Acceptance Criteria: The document does not define specific performance metrics (e.g., sensitivity, specificity, accuracy) or thresholds for those metrics that the Sea-Band needed to achieve.
- No Dedicated Performance Study: Instead of a study to prove performance against criteria, the submission relies on:
- "Published clinical evaluations": This refers to existing literature supporting the general principle of acupressure for nausea relief, and likely for the predicate devices. It does not describe a specific study conducted for this Sea-Band device with a predefined study design, sample size, or ground truth establishment.
- "Biocompatibility data": This relates to material safety, not clinical performance for nausea relief.
- "Bench testing of physical properties of realtime age data": This also relates to product integrity/durability, not clinical efficacy.
- Substantial Equivalence Argument: The core of the submission is that the Sea-Band is "substantially equivalent" to other legally marketed products (like the Acu-Band and ReliefBand® products) based on technological characteristics (applying pressure to the P6 point) and general indications for use.
Therefore, I cannot extract the following information:
- Table of Acceptance Criteria and Reported Device Performance: This information is not present.
- Sample size used for the test set and the data provenance: There is no described test set or clinical study for this specific device.
- Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done: No such study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical device, not an algorithm.
- The type of ground truth used: Not applicable, as there's no described clinical study for this specific device.
- The sample size for the training set: Not applicable (no algorithm).
- How the ground truth for the training set was established: Not applicable.
The submission focuses entirely on substantial equivalence to existing devices cleared by the FDA, implying that since the predicate devices are considered safe and effective, and this device is similar, it too should be considered safe and effective.
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510(k) SUMMARY
SUMMARY OF SAFETY AND EFFECTIVENESS FOR THE SEA-BAND LTD SEA-BAND
SUBMITTER INFORMATION
| Submitter Company Name | Sea-Band Ltd |
|---|---|
| Submitter Company Address | Sea-Band LtdLancaster RoadHinckleyLeicestershire LE10 0AWEngland |
| Submitter Telephone | 011 44 1455 639750 |
| Submitter Facsimile | 011 44 1455 639751 |
| Submitter Contact Person | Neil R. ArmstrongRegulatory Affairs Advisor to Sea-Band LtdMeddiQuest LimitedBusiness & Technology CenterBessemer DriveStevenage SG1 2DXEnglandTelephone: 011 44 1763 222505Fax: 011 44 1438 310001 |
| Date Summary Prepared | August 15, 2003 |
DEVICE IDENTIFICATION
Trade/Proprietary Name Classification Name
Sea-Band To be determined:
Mr. Ted Stevens, D.G.R.N.D. Branch Chief at O.D.E. was contacted requesting a classification determination on April 09,2002. This facsimile was treated as a 513(q) request for classification determination and passed to Mr. Steve Hinckley.
Since this time we have corresponded with Mr. Hinckley by e-mail, fax and telephone and in our latest telephone conversation (on 03/10/2003) Mr. Hinckley requested that we submit our 510(k) without Product Code, Regulation Number or Classification name.
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DEVICE DESCRIPTION
The "Sea-Band" consists of elasticated wrist band with a plastic button. The button is designed to apply pressure to the P6 or "nei-kuan", acupuncture point.
"Sea-Bands" are designed to be worn on each wrist and are supplied in pairs in a plastic case. The case is contained in an outer cardboard box with instructions for use.
The Sea-Band Ltd , Sea-Band will be available in a variety of different colors and pack types.
INDICATIONS FOR USE
The Sea-Band Ltd "Sea-Band" is indicated for the relief of nausea.
(Nausea is a symptom that may be experienced due to a variety of causes, for example:
- . Travel/Motion
- . Pregnancy (Morning Sickness)
- Chemotherapy .
- Post Operative) .
TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the Sea-Band Ltd "Sea-Band" and the predicate devices has been performed.
The only significant difference in technological characteristic is between the Sea-Band Ltd "Sea-Band" and the Woodside Biomedical, Inc. "Relief Bands®". The "Relief Bands®" products use electrical rather than pressure stimulation, however FDA has already determined substantial equivalence of these two methods of nerve stimulation (PreMarket Notification submissions made by Maven Laboratories Inc. for the original Relief Bands).
PERFORMANCE DATA
Published clinical evaluations, biocompatibility data and bench testing of physical properties of realtime age data demonstrate that the Sea-Band Ltd "Sea-Band" is safe and effective for its intended use and substantially equivalent to the predicate products.
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| Common/Usual NameClassification | See Classification Name aboveClass II |
|---|---|
| Ms. Gladys Rodriguez, Acting Director ofDivision of Enforcement III at the CDRH OfficeCompliance requested a 510(k) submission inher letter to Mr. Byron Chatburn, ManagingDirector of Sea-Band Ltd , of February 062002. | |
| Product Code | See Classification Name above |
IDENTIFICATION OF PREDICATE DEVICE
Substantial Equivalence to Acu-Band K900588
The Sea-Band manufactured by Sea-Band Ltd is substantially equivalent to the Acu-Band by Euro Am Pharma Inc.
Substantial Equivalence to various ReliefBand® Products
The Sea-Band Ltd "Sea-Band" is also substantially equivalent to various "Relief Band" products manufactured by Woodside Biomedical, Inc.
| K Number | Product |
|---|---|
| K020180 | ReliefBand® Device ModelsRB-DL, RB-EL and RB-RL |
| K994387 | ReliefBand® Device Models WB-2L,WB-6L, and WB-RL(Rx) |
| K983907 | ReliefBand® NSTTM Device ModelsWB-2L |
| K982967 | ReliefBand® Device Models RB-2, RB-6 and RB-R (OTC) |
| K982436 | ReliefBand® Device Models WB-2,WB-6, WB-R |
| K980333 | ReliefBand® Device Model SW-111 |
Substantial Equivalence to Other Products
Other similar products to the Sea-Band Ltd Sea-Band that are believed to have been marketed in the USA, and to which the Sea-Band may be substantially equivalent include:
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Travel Smart by Victor Kiam -NoQweez Motion Discomfort Wrist Bands - also makes claims for Motion sickness.
Franzus Company Inc. 10 Railroad Ave. Beacon Falls, CT06403 NoQweez is a Cirrus Air Technologies Trademark Model WVK-186NQ Made in USA Marketed by Wal Mart - box dated 1998 Made in USA
TRAVEL BAND - Claims for Travel and M/Sickness Danelco Industries Ltd. 4 - 12880 Bayhgate Way Richmond, BC Canada V6V 1Z4
VALET - TRAVELAIDE WRISTBANDS -Motion Sickness Mayday Inc. 1121 Chesnut Street Burbank CA 91506 Tel.310 305 7500 Made in USA
FIRST AID -- EZY TRAVELER WRISTBAND -- Motion Sickness Apothecary Products Inc. Minneapolis MN 55337 Made in USA
Davis – QUEAZ-AWAY Travelers' Wristbands David Instruments 3465 Diablo Ave. Haywood CA 945 45 Made in USA
Accu-Presure BANDS - for travel Standard Merchandising Co. Camden NJ 08103 Made in USA
RISSBAND - Motion Sickness and Pregnancy Rissband Inc. 100 Spark Street Brockton MA 02402 Made in USA Copyright on leaflet 1989
TRAVELGARDE Acupressure Wrist Band Marine Logic Inc. 400 Australian Ave. Suite 725 West Palm Beach FL. 33401 Tel 407 832 5112 Made in USA
BioBands - Morning Sickness - K822306 BioBands Inc. NY 10010 Patent 5078728 Made in USA
MedicMates – Anti Sickness Bands for sea travel and morning sickness MedicMates Ltd GU1 2DT (UK) Made in USA
Acuband - Travel Sickness nausea - K900588 AcuBand Ltd Suite 1B Market Centre Western International Market Hayes Rd. Southall Middlesex UK
THE TRAVELEZE -- Travel Sickness The Traveleze PO Box 30 Blundell Lane Bursledon Nr. Southampton UK
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized emblem featuring three horizontal lines that curve upwards, resembling a bird in flight or a stylized representation of human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 7 2004
Sea- Band UK Ltd. C/o Mr. Neil R. Armstrong MeddiQuest Limited Business & Technology Center, Bessemer Drive Stevenage, Herts. United Kingdom SG1 2DX
Re: K033268
Trade/Device Name: Sea-Band Limited - "SeaBand" Regulation Name: Accu pressure device Regulatory Class: Unclassified Product Code: MVV Dated: September 1, 2003 Received: October 9, 2003
Dear Mr. Armstrong:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such 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 I'DA'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); 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.
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Page 2 - Mr. Neil R. Armstrong
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 contact the Office of Compliance 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 responsibilitics under the Act from the Division of Small Manufacturers, International 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,
Mark N Wilkerson
Celia M. Witten, PhD, MD 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): K033268
Sea-Band Limited - "SeaBand" Device Name:
Indications For Use:
The Sea-Band Limited "Sea-Band" is indicated for the relief of nausea.
(Nausea is a symptom that may be experienced due to a variety of causes, for example:
- . Travel/Motion
- Pregnancy (Morning Sickness) .
- . Chemotherapy
- Post Operative) .
for Mark N Milkens
General Restorative Deleal Devices
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ V (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)
(Posted November 13, 2003)
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