(51 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description is also not available.
No
The device is used for tissue or fluid removal during general surgical procedures for aesthetic body contouring, which is a procedural tool rather than a therapeutic device that treats or cures a disease or condition.
No
Explanation: The device's intended use is the removal of tissue or fluid from the body during general surgical procedures for aesthetic body contouring. This describes a treatment or surgical intervention, not a diagnostic purpose.
No
The device description is not found, but the intended use clearly describes a physical cannula for tissue and fluid removal, which is a hardware component. The predicate device also appears to be a hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "removal of tissue or fluid from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring." This describes a surgical tool used on the body, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
The device is clearly described as a surgical instrument for tissue and fluid removal during a procedure.
N/A
Intended Use / Indications for Use
The Accelerator Reciprocating Cannula indications for use are the removal of tissue or fluid from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring.
Product codes
OPB, MUU
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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
§ 878.5040 Suction lipoplasty system.
(a)
Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.(b)
Classification. Class II (special controls). Consensus standards and labeling restrictions.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is commonly used to indicate that a product or establishment is regulated by the FDA.
Byron Medical Regina Harris Director, Regulatory Affairs 602 W Rillito St. Tucson, Arizona 85705
June 8, 2021
Re: K001803
Trade/Device Name: Accelerator Reciprocating Cannula Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: OPB
Dear Regina Harris:
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 August 4, 2000. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Cindy Chowdhury, OHT4: Office of Surgical and Infection Control Devices, 240-402-6647, Cindy.Chowdhury@fda.hhs.gov.
Sincerely,
Cindy Chowdhury -S
Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/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" arranged around the perimeter. Inside the circle is a stylized image of three abstract shapes resembling birds in flight, arranged in a row.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 2000 AUG
Ms. Regina S. Harris Director of Regulatory Affairs Byron Medical, Inc. 602 W. Rillito Street Tucson, Arizona 85705
Re: K001803
Trade Name: Accelerator Reciprocating Cannula Regulatory Class: II Product Code: MUU Dated: July 5, 2000 Received: July 13, 2000
Dear Ms. Harris:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Ms. Regina S. Harris
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Dume R. Lochner
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
3
510(k) Number (if known):
Accelerator Reciprocating Cannula Device Name:
Indications for Use:
The Accelerator Reciprocating Cannula indications for use are the removal of tissue or fluid from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dume R. Vochner.
(Division Sign-Off) (Division Sign-Off)
Division of General Restorative Devices
1991 Collect Coll Coll Coll Coll Coll Co Division of General Residents 510(k) Number _ E001803
Prescription Use
(Per 21 CFR 801.109
Over-The Counter Use
(Optional Format 1-2-96)
4
4 2000 AUG
Byron Medical Confidential - TRADE SECRET 510(k) SUMMARY
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92
| The assigned 510(k) number is: | K001803 |
|---|---|
| Submitted by: | Regina S. Harris |
| Director of Regulatory Affairs | |
| Byron Medical, Inc. | |
| 602 West Rillito Street | |
| Tucson, AZ 85705 | |
| Telephone #: | (520) 573-0857 |
| Facsimile #: | (520) 746-1757 |
| Date Prepared: | 19 May 2000 |
| Establishment Registration Number: | Byron Medical is located at 602 West Rillito |
| Street, Tucson, AZ 85705. We are registered | |
| with the Food and Drug Administration as | |
| Establishment Number 2025576. | |
| Classification Name: | Suction Lipoplasty Devices |
| 21 CFR § 878.5040 (1998) | |
| Manual Surgical Instrument for | |
| General Use | |
| 21 CFR § 878.4800 (1998) | |
| Surgical Instrument Motors and | |
| Accessories/ Attachments | |
| 21 CFR § 878.4820 (1998) | |
| Common/Usual Name: | |
| Instrument | Surgical Aspiration and Lipoplasty |
| Proprietary Name: | Accelerator Reciprocating Cannula |
| Indication for Use: | The Accelerator Reciprocating |
| Cannula indications for use are for | |
| removal of soft tissue or fluid from the | |
| body during general surgical procedures | |
| to include suction lipoplasty for the | |
| purpose of aesthetic body contouring. |
SECTION 04-01
5
Byron Medical Confidential
RE: K001803 (Comment Response Letter to FAX: 05 July 2000) 510(k) Submission: Accelerator Reciprocating Cannula
More Detailed Substantial Equivalence Comparison with respect to rate and travel distance.
| Cannula
Action | Summary | Byron
Medical
Accelerator
Reciprocating
Cannula | MicroAire
PAD system | Byron Medical -
Traditional
Cannula powered
by average
physician |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Rate of Movement | Is much lower than the
MicroAire device, and
slightly higher that
traditional manual
movement.
Thus, safely between the
two existing technologies. | 0-800 cpm –
adjustable for
variable surgeon
technique and
tissue variance
patient to patient. | 0 and 4,000 cpm
non adjustable. | 0 - 250 cpm
based on
physician stroke
length. Not an
easily
maintainable rate. |
| Distance Travels | Very similar to the
MicroAire device, and
considerably less than
traditional | 0, ¼" and ½" | 0, 1/10" and ¼" | 0 - 12"+ |
| Cannula
attached | Very similar to both
existing technologies | 2-6mm | 3.9-5mm | 2-6mm |
| Force | Less than both existing
modalities, and presents
surgeons with consistent
controlled movement.
Also, the Byron
Accelerator
Reciprocating Cannula
is the only device that
provides a safety
mechanism, that when
greater than 41 lbs of force
is applied, the
reciprocation stops to
identify to surgeons that
they are exerting greater
than 40 lbs of force in
dense tissue. | 41 lbs of
force | 60+ lbs of force
The physician
can overcome
this force and
apply 60 +
physician force
to be a very large
delivery force. | 50+ lbs of force |
| Summary | With respect to
function, the Byron
Medical Reciprocating
Cannula is as safe as the
Existing Modalities with
An additional safety
feature of a relief
mechanism of not applying
a joint force of physician
use greater than 41lbs of
force | | | |