ACCELERATOR RECIPROCATING CANNULA

K001803 · Byron Medical · QPB · Aug 4, 2000 · General, Plastic Surgery

Device Facts

• Record ID: K001803
• Device Name: ACCELERATOR RECIPROCATING CANNULA
• Applicant: Byron Medical
• Product Code: QPB · General, Plastic Surgery
• Decision Date: Aug 4, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5040
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Accelerator Reciprocating Cannula is a surgical instrument used for suction lipoplasty and general tissue/fluid removal. Device provides reciprocating motion to a cannula to assist surgeons in body contouring procedures. Operated by physicians in a clinical/surgical setting. Device features adjustable reciprocation rates (0-800 cpm) and variable stroke lengths (0, 1/4", 1/2"). Includes a safety mechanism that halts reciprocation when applied force exceeds 41 lbs, alerting the surgeon to excessive force in dense tissue. Provides consistent, controlled movement compared to manual techniques; reduces physical effort required by the surgeon.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparative performance analysis of mechanical parameters (rate, travel distance, force).

Technological Characteristics

Surgical reciprocating cannula; adjustable reciprocation rate (0-800 cpm) and stroke length (0, 1/4", 1/2"); mechanical force-limiting safety mechanism (stops at >41 lbs force); compatible with 2-6mm cannulas.

Indications for Use

Indicated for removal of soft tissue or fluid from the body during general surgical procedures, including suction lipoplasty for aesthetic body contouring.

Regulatory Classification

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 of 1/3 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.

Special Controls

*Classification.* Class II (special controls). Consensus standards and labeling restrictions.

Predicate Devices

• MicroAire PAD system

Submission Summary (Full Text)

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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, [e-mail].

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

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#### 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.

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#### 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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510(k) Number (if known):

K001803

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)

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#### 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<br>Director of Regulatory Affairs<br>Byron Medical, Inc.<br>602 West Rillito Street<br>Tucson, AZ 85705 |
| Telephone #: | [phone] |
| Facsimile #: | [phone] |
| Date Prepared: | 19 May 2000 |
| Establishment Registration Number: | Byron Medical is located at 602 West Rillito<br>Street, Tucson, AZ 85705. We are registered<br>with the Food and Drug Administration as<br>Establishment Number 2025576. |
| Classification Name: | Suction Lipoplasty Devices<br>21 CFR § 878.5040 (1998)<br>Manual Surgical Instrument for<br>General Use<br>21 CFR § 878.4800 (1998)<br>Surgical Instrument Motors and<br>Accessories/ Attachments<br>21 CFR § 878.4820 (1998) |
| Common/Usual Name:<br>Instrument | Surgical Aspiration and Lipoplasty |
| Proprietary Name: | Accelerator Reciprocating Cannula |
| Indication for Use: | The Accelerator Reciprocating<br>Cannula indications for use are for<br>removal of soft tissue or fluid from the<br>body during general surgical procedures<br>to include suction lipoplasty for the<br>purpose of aesthetic body contouring. |

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# 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<br>Action | Summary | Byron<br>Medical<br>Accelerator<br>Reciprocating<br>Cannula | MicroAire<br>PAD system | Byron Medical -<br>Traditional<br>Cannula powered<br>by average<br>physician |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Rate of Movement | Is much lower than the<br>MicroAire device, and<br>slightly higher that<br>traditional manual<br>movement.<br>Thus, safely between the<br>two existing technologies. | 0-800 cpm –<br>adjustable for<br>variable surgeon<br>technique and<br>tissue variance<br>patient to patient. | 0 and 4,000 cpm<br>non adjustable. | 0 - 250 cpm<br>based on<br>physician stroke<br>length. Not an<br>easily<br>maintainable rate. |
| Distance Travels | Very similar to the<br>MicroAire device, and<br>considerably less than<br>traditional | 0, ¼" and ½" | 0, 1/10" and ¼" | 0 - 12"+ |
| Cannula<br>attached | Very similar to both<br>existing technologies | 2-6mm | 3.9-5mm | 2-6mm |
| Force | Less than both existing<br>modalities, and presents<br>surgeons with consistent<br>controlled movement.<br><br>Also, the Byron<br>Accelerator<br>Reciprocating Cannula<br>is the only device that<br>provides a safety<br>mechanism, that when<br>greater than 41 lbs of force<br>is applied, the<br>reciprocation stops to<br>identify to surgeons that<br>they are exerting greater<br>than 40 lbs of force in<br>dense tissue. | 41 lbs of<br>force | 60+ lbs of force<br><br>The physician<br>can overcome<br>this force and<br>apply 60 +<br>physician force<br>to be a very large<br>delivery force. | 50+ lbs of force |
| Summary | With respect to<br>function, the Byron<br>Medical Reciprocating<br>Cannula is as safe as the<br>Existing Modalities with<br>An additional safety<br>feature of a relief<br>mechanism of not applying<br>a joint force of physician<br>use greater than 41lbs of<br>force | | | |

# SECTION 03-15