The Synergetics Sterile Adjustable Gas Pressured Infusion Tube Set is intended to deliver forced humidified air or fluid to the eye during ophthalmic surgery.

Device Description

The Synergetics AGPI Tubing set is a PVC tubing set intended to deliver forced humidified air or fluid to the eye during ophthalmic surgery. The tubing set consists of a three channel IV spike, for insertion into a bottle of Balanced Salt Solution. The three way spike is designed to deliver air from an air supply unit through the solution; while the dual PVC tubing also administers humidified air (clear lumen) and saline (green stripe lumen); this dual PVC tubing has a three-way stopcock for proper connection.

AI/ML Overview

This document describes the Synergetics Adjustable Gas Pressured Infusion (AGPI) Tube Set, a device intended to deliver forced humidified air or fluid to the eye during ophthalmic surgery. The document is primarily a 510(k) submission, focusing on establishing substantial equivalence to predicate devices, rather than a clinical study report with detailed acceptance criteria and performance metrics in the context of diagnostic accuracy or clinical outcomes.

Therefore, many of the requested sections regarding acceptance criteria, study design, sample sizes for test and training sets, expert qualifications, and ground truth establishment cannot be fully addressed from the provided text, as this information is typically found in performance studies, which are not detailed here. The submission focuses on technical and safety aspects for regulatory approval.

However, I can extract the available relevant information about the device and its compliance.

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity) in the sense of a clinical or analytical performance study. Instead, it focuses on demonstrating substantial equivalence to predicate devices by comparing technical characteristics and adherence to regulatory standards.

The primary "acceptance criteria" can be inferred as meeting the technical characteristics and safety/sterilization standards demonstrated by predicate devices and relevant ISO standards.

Criteria (Inferred from comparison table and standards)	Predicate Devices (Peregrine Wet Set, Alcon VGFI Tube Set)	Synergetics AGPI Tube Set Performance (as reported for equivalence)
Intended Use (Delivery of forced humidified air/fluid to eye during ophthalmic surgery)	Yes	Yes (Stated as the device's intended use)
Pressured Air Delivered from Fluid Source (Bottle/system console)	Yes	Yes (Bottle/system console)
Fluid Source (Bottle)	Yes	Yes (Bottle)
Air System Required	Yes	Yes
3-way Stopcock for air/fluid selection	Yes	Yes
Extension tube for insertion into BSS Solution	Yes	Yes
Delivery line for air to stopcock	Yes	Yes
Delivery line for fluid to stopcock	Yes	Yes
Filtered Air Line for attachment to air system	Yes	Yes
Single Use	Yes	Yes
Sterilization Method (Ethylene Oxide - EtO)	Yes	Ethylene Oxide (EtO) (Validated per AAMI/ISO 11135)
Packaging Validation (Compliance with ISO 11607-1:2006 for Sterile Barrier Systems)	Not known (for Peregrine), Rigid PETG Tray (for Alcon)	Tyvek/Mylar Pouch (Validated per ISO 11607-1:2006)
Quality Management System Compliance	Implied for predicate devices	BS EN 13485:2003 compliant
Risk Management Compliance	Implied for predicate devices	ISO 14971, GHTF/SGS/N15R8 compliant

Study Information (Based on available text)

Sample size used for the test set and the data provenance:
- The document does not describe a "test set" in the context of a clinical performance study with a sample size for human subjects or case data. The "test set" here refers to the device itself being evaluated against technical and regulatory standards.
- Data provenance is primarily through comparison with existing predicate devices (Peregrine Wet Set, Alcon VGFI Tube Set) and established international standards (ISO 11607-1:2006, AAMI/ISO 11135, ISO 14971, BS EN 13485:2003). This is therefore "retrospective" analysis of existing regulatory and technical standards and comparison to previously approved devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in this context. The "ground truth" for this type of submission is adherence to predefined technical specifications and regulatory standards, rather than expert-derived diagnoses or interpretations. The FDA reviewers (e.g., in the Ophthalmic Panel) represent regulatory expertise.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There's no clinical "test set" requiring adjudication of results. The adjudication process would be the regulatory review conducted by the FDA.
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:
- Not applicable. This device is a medical accessory (tubing set), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness assessment was conducted or is relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithmic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this 510(k) submission relates to technical specifications, safety, and performance as defined by engineering standards, manufacturing controls, and the established characteristics of predicate devices. For example, the ground truth for sterilization is adherence to AAMI/ISO 11135, and for packaging, it's ISO 11607-1:2006.
The sample size for the training set:
- Not applicable. There is no concept of a "training set" for this type of medical device submission. The device is not learning from data.
How the ground truth for the training set was established:
- Not applicable.

Summary

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Synergetics Adjustable Gas Pressured Infusion Tube Set Section 5 510 (k) Summary Submitted in accordance with the requirements of 21 CFR 807.92

Applicant's Name and Address:	Synergetics, Inc.3845 Corporate Centre DriveO'Fallon, MO 63368
Contact Person:	Gary OliverosSynergetics, Inc.Quality Systems/ Regulatory Affairs ManagerPhone: (636) 794-5107Fax: (636) 794-5120Email: goliveros@synergeticsusa.com

OCT 3 0 2009

Date Prepared:	May 14, 2009
Device Trade Name:	Synergetics Sterile Adjustable Gas Pressured Infusion (AGPI) Tube Set
Common Name:	Air/ Fluid Tubing Set
Device Classification:	Class II
Class Name:	A review of the U.S. FDA's Product Code Classification Files athttp://www.fda.gov/cdrh/prdcddes.html indicates a similar typedevice is not listed in 21 CFR Parts 862 - 892.
Product Code:	FRN
FDA Panel:	Ophthalmic
Predicate Device:	Peregrine Wet Set, K990518

Intended Use/ Device Description:

Substantial Equivalence Basis:

This premarket notification contains descriptive information related to the intended use, operational characteristics and technological features that provide objective evidence that forms the basis of a substantial equivalence decision.

Section 5 - Page 1 of 2

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Comparison of Technical Characteristics:

Predicate Device Comparison
Criteria	Predicate DevicePeregrine Wet SetK990518	Predicate DeviceAlcon VGFI Tube SetK911808	Synergetics, Inc.AGPI Tube Set
Indications for Use
Pressured Air Delivered fromFluid Source	Bottle	Bottle/ system console	Bottle/ system console
Fluid Source	Bottle	Bottle	Bottle
Air System Required	Yes	Yes	Yes
3 way stopcock for air/ fluidselection	Yes	Yes	Yes
Extension tube for insertion intoBSS Solution	Yes	Yes	Yes
Delivery line for air to stopcock	Yes	Yes	Yes
Delivery line for fluid tostopcock	Yes	Yes	Yes
Filtered Air Line for attachmentto air system	Yes	Yes	Yes
Single Use	Yes	Yes	Yes
Sterilization Method	Ethylene Oxide (EtO)	Ethylene Oxide (EtO)	Ethylene Oxide (EtO)
Packaging (See Note 1)	Not known	Rigid PETG Tray	Tyvek/ Mylar Pouch
Note 1: Synergetics packaging configuration has been validated in accordance with ISO 11607-1:2006,Packaging for Terminally Sterilized Medical Devices- Part 1: Requirements for Materials, Sterile BarrierSystems and Packaging Systems

Quality Management System:

Synergetics is a BS EN 13485:2003 compliant company and is required to ensure our quality management system and design control practices fully comply with internal quality system standards and domestic regulations. Pursuant to our design control process, Synergetics has established a risk management process that ensures during the design validation phase, the safety and effectiveness of the device meets applicable input requirements and complies with applicable harmonized standards.

Risk Management:

Risk Management has been implemented and complies with ISO 14971, Medical Devices - Application of Risk Management to Medical Devices and GHTF/SGS/N15R8, Implementation of Risk Management Principles and Activities within a Quality Management System.

Sterilization Method:

Synergetics Adjustable Gas Pressured Infusion Tube Sets are sterilized in accordance with AAMI/ISO 11135 Medical Devices - Validation and routine control of ethylene oxide sterilization (EtO), Overkill Method.

Section 5 - Page 2 of 2

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Synergetics, Inc. c/o Mr. Gary Oliveros Quality System/Regulatory Affairs Manager 3845 Corporate Centre Drive O' Fallon, MO 63368

OCT 8 0 2009

Re: K091441

Trade/Device Name: Synergetics Adjustable Gas Pressurized Infusion (AGPI) Tube Set Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: October 9, 2009 Received: October 13, 2009

Dear Mr. Oliveros:

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 indications 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 Mcdical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, 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, 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 (PMA), it may be subject to 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Kesia Alexander for

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Synergetics™ 510 (k) Submission Synergetics Adjustable Gas Pressured Infusion (AGPI) Tube Set Section 4 - Indications for Use

510(k) Number (if known):

Synergetics Adjustable Gas Pressured Infusion (AGPI) Tube Set Device Name: The Synergetics Sterile Adjustable Gas Pressured Infusion Tube Indications for Use: Set is intended to deliver forced humidified air or fluid to the eye during ophthalmic surgery.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daryl Kautner

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear Nose and Throat Devices

510(k) Number__

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).