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 Description

Not Found

AI/ML Overview

The provided documents pertain to the FDA 510(k) clearance for the Accelerator Reciprocating Cannula by Byron Medical. This is a medical device submission, specifically a predicate comparison, not a study that proves a device meets acceptance criteria in the typical sense of a clinical trial or performance study against specific metrics.

Therefore, I cannot provide the information requested in the format of acceptance criteria and the study that proves the device meets them, as this document type does not contain such a study or detailed performance metrics.

However, I can extract the information that is present, focusing on the comparative effectiveness study (which is a comparison to predicate devices for substantial equivalence, not a clinical trial proving new acceptance criteria).

Here's a breakdown of what can be extracted or inferred from the provided FDA 510(k) summary regarding the requested points:

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

The document does not establish explicit "acceptance criteria" for the Accelerator Reciprocating Cannula in the way a clinical performance study would. Instead, it demonstrates substantial equivalence to legally marketed predicate devices. The "performance" is reported within a comparative table against these predicates on certain functional attributes.

Criteria (Functional Attribute for Substantial Equivalence)	Reported Device Performance (Byron Medical Accelerator Reciprocating Cannula)	Predicate Device 1 (MicroAire PAD system) Performance	Predicate Device 2 (Byron Medical - Traditional Cannula) Performance (Manual)
Rate of Movement	0-800 cpm – adjustable	0 and 4,000 cpm non adjustable	0 - 250 cpm (based on physician stroke length; not easily maintainable)
Distance Travels	0, ¼" and ½"	0, 1/10" and ¼"	0 - 12"+
Cannula Attached (Size/Diameter)	2-6mm	3.9-5mm	2-6mm
Force (during operation)	41 lbs of force (with safety mechanism that stops reciprocation if > 41 lbs)	60+ lbs of force (can be overcome by physician)	50+ lbs of force
Safety Feature	Reciprocation stops when > 41 lbs of force is applied.	None explicitly mentioned	None explicitly mentioned
Overall Summary of Equivalence	"as safe as the Existing Modalities with An additional safety feature"

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable in the context of a clinical test set. The submission focuses on a comparison of device specifications and operational characteristics to predicate devices. No human subject testing data (test set) is provided or referenced here.
Data Provenance: The data is a comparison of technical specifications and operating parameters, likely derived from engineering testing, functional analysis, and manufacturer specifications of the Byron Medical device and its predicate devices. No country of origin for a "test set" or information about retrospective/prospective collection is relevant here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable. There was no "test set" in the sense of patient data or images requiring expert adjudication. The "ground truth" for this type of submission is the documented performance characteristics of the devices and their equivalence.

4. Adjudication method for the test set

Not applicable, as there was no test set requiring adjudication.

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

This is not applicable. The device (Accelerator Reciprocating Cannula) is a surgical instrument (a cannula for liposuction), not an AI-powered diagnostic imaging device. Therefore, no MRMC study involving human readers or AI assistance was performed or is relevant to this submission.

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

Not applicable, as this is a physical surgical instrument, not an algorithm or AI system.

7. The type of ground truth used

For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is based on the technical specifications, functional performance characteristics, and intended use comparison of the proposed device against legally marketed predicate devices. This includes physical measurements, operational parameters (e.g., cpm, travel distance, force), and safety features, substantiated through engineering and non-clinical testing data (not provided in detail in this summary) and comparison with predicate device information.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm.

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

Not applicable. No training set exists for this type of device.

Summary

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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, 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

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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.

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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 (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

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510(k) Number (if known):

K001803

Accelerator Reciprocating Cannula Device Name:

Indications for Use:

(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. HarrisDirector of Regulatory AffairsByron Medical, Inc.602 West Rillito StreetTucson, 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 RillitoStreet, Tucson, AZ 85705. We are registeredwith the Food and Drug Administration asEstablishment Number 2025576.
Classification Name:	Suction Lipoplasty Devices21 CFR § 878.5040 (1998)Manual Surgical Instrument forGeneral Use21 CFR § 878.4800 (1998)Surgical Instrument Motors andAccessories/ Attachments21 CFR § 878.4820 (1998)
Common/Usual Name:Instrument	Surgical Aspiration and Lipoplasty
Proprietary Name:	Accelerator Reciprocating Cannula
Indication for Use:	The Accelerator ReciprocatingCannula indications for use are forremoval of soft tissue or fluid from thebody during general surgical proceduresto include suction lipoplasty for thepurpose of aesthetic body contouring.

SECTION 04-01

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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.

CannulaAction	Summary	ByronMedicalAcceleratorReciprocatingCannula	MicroAirePAD system	Byron Medical -TraditionalCannula poweredby averagephysician
Rate of Movement	Is much lower than theMicroAire device, andslightly higher thattraditional manualmovement.Thus, safely between thetwo existing technologies.	0-800 cpm –adjustable forvariable surgeontechnique andtissue variancepatient to patient.	0 and 4,000 cpmnon adjustable.	0 - 250 cpmbased onphysician strokelength. Not aneasilymaintainable rate.
Distance Travels	Very similar to theMicroAire device, andconsiderably less thantraditional	0, ¼" and ½"	0, 1/10" and ¼"	0 - 12"+
Cannulaattached	Very similar to bothexisting technologies	2-6mm	3.9-5mm	2-6mm
Force	Less than both existingmodalities, and presentssurgeons with consistentcontrolled movement.Also, the ByronAcceleratorReciprocating Cannulais the only device thatprovides a safetymechanism, that whengreater than 41 lbs of forceis applied, thereciprocation stops toidentify to surgeons thatthey are exerting greaterthan 40 lbs of force indense tissue.	41 lbs offorce	60+ lbs of forceThe physiciancan overcomethis force andapply 60 +physician forceto be a very largedelivery force.	50+ lbs of force
Summary	With respect tofunction, the ByronMedical ReciprocatingCannula is as safe as theExisting Modalities withAn additional safetyfeature of a reliefmechanism of not applyinga joint force of physicianuse greater than 41lbs offorce

SECTION 03-15

Regulation Number and Section

§ 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.