(243 days)
Not Found
No
The device description and the absence of mentions of AI, DNN, ML, training sets, test sets, or performance studies related to algorithmic performance strongly suggest that this is a mechanical acupressure device without AI/ML.
Yes
The device is intended for the relief of nausea, which is a medical symptom, thus it aims to treat or alleviate a medical condition.
No
The device is intended for the relief of nausea by applying pressure to an acupressure point, not for diagnosing any medical condition.
No
The device description clearly states that the device consists of physical wrist bands with a button, indicating it is a hardware device, not software-only.
Based on the provided information, the Acubands 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.
- Acubands Function: The Acubands device works by applying physical pressure to an acupressure point on the wrist. It does not involve the analysis of any biological samples.
- Intended Use: The intended use is for the relief of nausea through physical pressure, not through diagnostic testing.
Therefore, the Acubands fall under the category of a physical medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Acubands are indicated for the relief of nausea. Nausea is a symptom which can be experienced by causes such as motion sickness, morning sickness (pregnancy), chemotherapy and post-operative from anesthesia.
Product codes
MVV
Device Description
The Acubands consist of a pair of wrist bands with a half-round button affixed to the interior side of the band. The Acubands are made of hook and loop fabric which allows the wrist band to be fully adjustable. The Acuband wrist bands enable the button to apply gentle pressure on the acupressure point, the P6 or Nei-Kuan, point on the inner wrist. This action interrupts the signal that triggers nausea.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
inner wrist
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
BioBands (K051397), Acu-Strap (K041877), Sea-Band (K033268), Ezy-Travel Band (K041766)
Reference Device(s)
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
510K SUMMARY RE: KO53509
Submitter Information:
AUG 1 6 2006
| >Acuband Incorporated | 101 Little Silver Point Road, Little Silver, NJ 07739 |
|---|---|
| >Telephone: | 732-219-9166 |
| >Fax: | 732-219-8972 |
| >Contact Person: | Richard Griffith |
| >Date Summary Prepared: | July 18, 2006 |
| Device Identification: | |
| >Device name: | Acuband |
| >Classification name: | Acupressure wrist band |
| FDA Approved Predicate Devices: | |
| > BioBands (K051397) | |
| >Acu-Strap (K041877) |
Sea-Band (K033268)
Ezy-Travel Band (K041766)
Device Description:
The Acubands consist of a pair of wrist bands with a half-round button affixed to the interior side of the band. The Acubands are made of hook and loop fabric which allows the wrist band to be fully adjustable. The Acuband wrist bands enable the button to apply gentle pressure on the acupressure point, the P6 or Nei-Kuan, point on the inner wrist. This action interrupts the signal that triggers nauses.
Intended Use:
Acubands are indicated for the relief of nausea. Nausea is a symptom which can be experienced by causes such as motion sickness, morning sickness (pregnancy), chemotherapy and post-operative from and thesia.
1
510K Summary Page 8.2
Technological Characteristics:
The Acubands are constructed in the same manner as Bio-Bands (K051397). The Acubands utilize velcro hook and loop fabric for the band material which allows each band to be fully adjustable. The Acubands are sold as a pair and 1 band is intended to be worn on each wrist. The plastic button, located on the center of the interior side of the Acuband, is similar to the buttons in dimension and composition as the following predicate devices: Bio-Bands (K051397); Acu-Strap (K041877); Sea Band (K033268).
The Acuband wrist band is substantially equivalent to the products in terms of intended use, materials, dimension and mechanical characteristics.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: a circular text border and a stylized symbol in the center. The text border reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement. The central symbol features three abstract human profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 6 2006
Acuband, Inc. c/o Mr. Richard Griffith III President 101 Little Silver Point Road Little Silver, New Jersey 07739
Re: K053509
Trade Name: Acuband™M Regulatory Class: Unclassified Product Code: MVV Dated: August 1, 2006 Received: August 15, 2006
Dear Mr. Griffith:
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 iudications 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, Or og, 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, isting 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 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. Your must comply with all the Act's requirements, including, but not limited to: registress. "Touridation 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 100-1000. 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.
3
Page 2 -- Mr. Richard Griffith III
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milliken
Mark N. Melkerson, M.S Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
101 Little Silver Point Rd Little Silve> NJ 07739 Phone 800-831-8777 Fax 732- 219-8972
Pg. 3
INDICATIONS FOR USE
510(K) Number: KO53509
Device Name: ACUBAND
Indications for Use:
Acubands are indicated for the relief of nausea. Nausea is a symptom which can be experienced by causes such as motion sickness, morning sickness (pregnancy), chemotherapy
and nost operative from another is and post operative from anesthesia.
Prescription Use (Part 21 CFR 801 Subpart D)
And/Or
Over-the-Counter Use X (21 CFR 801 Subpart C)
Murle A. Melleum
Division Sign-Off) Division of General, Restorative and Neurological Devices 5 10(k) Number --