BioBands is indicated for the relief of nausea. Nausea may be experienced due to a variety of causes, including Travel (Motion Sickness), Pregnancy (Morning Sickness), Anesthesia (Post-Operative) or Chemotherapy.

Device Description

BioBands is an adjustable wristband that fits on either wrist. The device is composed from nylon and polyester fabric, and features a Velcro closure for easy adjustment. The BioBands wristband has a wooden bead or button sewn into the band's underside. When BioBands is worn by users, the wooden bead applies pressure to the P6 or "nei-kuan" acupuncture point. The gentle pressure applied by the bead to the P6 interrupts the signals that trigger nausea.

AI/ML Overview

The provided text is a 510(k) summary for the BioBands device, which is an acupressure wristband. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study data in the way a de novo or PMA submission would.

Therefore, much of the requested information (such as specific acceptance criteria based on performance metrics like sensitivity/specificity, detailed study designs, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not present in this document. The document's purpose is to establish equivalence, not to prove specific performance against quantitative criteria in a new study.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

This document does not specify quantitative acceptance criteria or report specific device performance metrics (e.g., sensitivity, specificity, accuracy, or reduction in nausea scores) from a new clinical study. The basis for acceptance is substantial equivalence to predicate devices, which implies that if the predicate devices were considered safe and effective for the stated indications, then BioBands, being "similarly constructed" and using the "same principal of operation" for the "same indications for use," would also be considered safe and effective.

Acceptance Criteria (Inferred from Substantial Equivalence Basis)	Reported Device Performance (Inferred from Substantial Equivalence Basis)
Similar design and construction to predicate devices.	BioBands is "similarly constructed" to K033268 and K041877.
Same principle of operation as predicate devices.	BioBands utilizes the "same principal of operation" as K033268 and K041877 (applying pressure to P6 point).
Same intended use/indications for use as predicate devices.	BioBands is "marketed for the same indications for use" as K033268 and K041877. (Relief of nausea from motion sickness, morning sickness, post-operative, and chemotherapy).
Safe and effective for intended use (implied by predicate clearance).	Implied to be safe and effective based on equivalence to cleared predicate devices.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Sample size for test set: Not applicable and not mentioned. No specific test set for BioBands performance is described.
Data provenance: Not applicable. The document relies on the regulatory clearance of predicate devices rather than new clinical data.

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):

Number of experts/qualifications: Not applicable and not mentioned. No specific ground truth establishment for a test set is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Adjudication method: Not applicable and not mentioned. No test set requiring expert adjudication is described.

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:

MRMC study: No. This device is a physical acupressure band, not an AI or imaging device, so an MRMC study is not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Standalone study: No. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Type of ground truth: Not applicable. The "ground truth" here is effectively the prior regulatory clearance of the predicate devices based on their established safety and efficacy, or public domain knowledge about acupressure for nausea. The document doesn't describe establishing new ground truth for BioBands through clinical outcomes or expert consensus.

8. The sample size for the training set:

Sample size for training set: Not applicable and not mentioned. There is no algorithm or model described that would require a training set.

9. How the ground truth for the training set was established:

How ground truth was established: Not applicable and not mentioned. No training set or ground truth for it is described.

Summary of Study Information based on the provided document:

The provided 510(k) summary does not describe a new clinical study to establish acceptance criteria or device performance. Instead, it relies on demonstrating substantial equivalence to two legally marketed predicate devices: K033268 ("Sea-Band" wristband) and K041877 (Acu-Strap Motion Sickness Band).

Basis for Substantial Equivalence: BioBands is described as "similarly constructed" to the predicates, utilizes the "same principal of operation" (applying pressure to the P6 or "nei-kuan" acupuncture point), and is "marketed for the same indications for use" (relief of nausea due to Travel, Pregnancy, Anesthesia, or Chemotherapy).
No new clinical data/studies presented: The document does not provide details of any specific clinical trials, performance studies, sample sizes, expert-adjudicated ground truth, or statistical analysis for the BioBands device itself. The regulatory acceptance is based on its similarity to already cleared devices.

Summary

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SEP 1 6 2005 510(k) Summary

Applicant/Address

BioBands Distributors, Inc., 30 Waterside Plaza, Suite 36K, New York, NY 10010 0

Contact Person/Telephone

Georgia C. Ravitz, Counsel to BioBands Distributors, Inc., (PH) 202-857-8939; (FAX) ០ 202-857-6395.

Preparation Date

0 May 18, 2005
Device Trade Name
- ロ BioBands

Classification Name

Acu-pressure Device 0

Legally Marketed Predicate Devices

K033268, "Sea-Band" wristband, by Sea-Band UK, Ltd; and K041877, Acu-Strap ០ Motion Sickness Band, by Health Enterprises, Inc.

Device Description

BioBands is an adjustable wristband that fits on either wrist. The device is composed ם from nylon and polyester fabric, and features a Velcro closure for easy adjustment. The BioBands wristband has a wooden bead or button sewn into the band's underside. When BioBands is worn by users, the wooden bead applies pressure to the P6 or "nei-kuan" acupuncture point. The gentle pressure applied by the bead to the P6 interrupts the signals that trigger nausea.

Intended Use

BioBands is indicated for the relief of nausea may be experienced due to a ០ variety of causes, including Travel (Motion Sickness), Pregnancy (Morning Sickness), Anesthesia (Post-Operative) or Chemotherapy.

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Substantial Equivalence Summary

a BioBands is substantially equivalent to K033268, "Sea-Band" wristband, by Sea-Band BioBands is also substantially equivalent to K041877, Acu-Strap Motion UK, Ltd. Sickness Band, by Health Enterprises, Inc. Both of these devices are similarly constructed wristbands, that utilize the same principal of operation, and that are marketed for the same indications for use.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is rendered in black and white.

SEP 1 6 2005

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

BioBands Distributors, Inc. c/o Mr. James H. Hartten Regulatory Affairs Analyst Arent Fox PLLC 1050 Connecticut Avenue, NW Washington, DC 20036-5339

Re: K051397

Trade/Device Name: BioBands Regulatory Class: Unclassified Product Code: MVV Dated: August 5, 2005 Received: August 5, 2005

Dear Mr. Hartten:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused 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 encreated of the enactment date of the Medical Device Amendments, or to conninered pror to May 20, 1970, as can one with the provisions of the Federal Food, Drug, de nece mat have act (Act) that do not require approval of a premarket approval application (PMA). and Cosmeter For ( 100 ) was the device, subject to the general controls provisions of the Act. The r ou may, mercrore, mains of the Act include requirements for annual registration, listing of general obtarely profice, 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 If your device is onastired (tional controls. Existing major regulations affecting your device can may be our 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 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 or any I subtar 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 El R Far 8073, accems (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. James H. Hartten

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oegin manteing of substantial equivalence of your device to a legally premarket notification: "The Pine of 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 specific advice for your as novel on one of the regulation entitled, Comation of Complianse w (2 + n notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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. Melkerson
Acting 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

KOS1397 510(k) Number (if known):

BioBands Device Name:

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_KOS) 397

Page _ 1_ of _l

0 000 9

Regulation Number and Section

N/A