(35 days)
Not Found
No
The description focuses on the mechanical function of a suction and irrigation system and does not mention any AI/ML components or capabilities.
No.
The device is used to deliver sterile irrigant solution and remove debris during surgery, which are supportive functions for a medical procedure rather than directly treating a disease or condition.
No
The provided text explicitly states that the Epix® Suction Irrigation System is intended as a "general purpose suction and/or irrigation device" that "delivers sterile irrigant solution and serves as a conduit for suction." There is no mention of the device being used to diagnose conditions, analyze data for diagnostic purposes, or provide information for medical diagnosis. Its function is solely described as providing irrigation and suction during surgery.
No
The device description clearly states it includes a reusable pump (hardware) and a sterile, single-use tubing set (hardware). It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "general purpose suction and/or irrigation" during surgical procedures. It delivers sterile irrigant solution and serves as a conduit for suction to remove fluids, debris, and smoke from the surgical site. This is a surgical device used during a procedure, not a device used to perform tests on samples taken from the body to diagnose conditions.
- Device Description: The description reinforces its function as a pump and tubing system for suction and irrigation during surgery.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in samples
- Providing diagnostic information about a patient's health status
The device's function is purely mechanical and supportive during a surgical procedure.
N/A
Intended Use / Indications for Use
The Epix® Suction Irrigation System is intended as a general purpose suction and/or irrigation device for use in laparoscopic and open general surgery, laparoscopic and open gynecological surgery, and laparoscopic and open urologic surgery. This device delivers sterile irrigant solution and serves as a conduit for suction.
Product codes
GCX, HET, KQT, BTA
Device Description
The Epix Irrigation Pump (model C7000) is reusable and operates outside of the sterile field. The Epix Suction Irrigation Tubing Set (model C7100) is a sterile, single use device, used in conjunction with the Epix Irrigation Pump and the house vacuum to deliver sterile irrigation fluids and to evacuate blood, tissue debris, and smoke from the surgical site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Operative site during laparoscopic and open procedures (general surgery, gynecological surgery, urologic surgery).
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
Applied Medical created a testing protocol to confirm substantial equivalency between the subject and predicate. The devices were tested side-by-side to evaluate substantial equivalence in performance in a laboratory setting. The bench top tests seen in Table 5-2 were designed to focus on the functional performance of both the suction and irrigation features. The subject device was also evaluated by a tubing collapse test based on an applicable section of ISO 10079-3 - Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench top tests, including Irrigation Fluid Flow Test, Irrigation Fluid Leak Test, Aspiration Fluid Flow Test, and Smoke Evacuation Flow Test. A tubing collapse test was also performed. Testing demonstrates that the subject Epix Suction Irrigation System is substantially equivalent to the predicate Stryker Cassette Pump.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.
0
Page 1 of 2
510(k) Summary
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c).
| 510(K) Submitter: | 22872 Avenida Empresa
(949) 713-8000 | Applied Medical Resources Corporation
Rancho Santa Margarita, CA, 92688 | ОСТ
2 2012 | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------------|--|
| Contact Person: | Jessica Cho
Regulatory Affairs Specialist
Applied Medical Resources
jcho@appliedmedical.com
Tel: (949) 713-8470 ext. 6697
Fax: (949) 713-8205 | | | |
| Date of Preparation: | August 24, 2012 | | | |
| Trade Name: | Epix® Suction Irrigation System | | | |
| Common Name: | Suction Irrigator | | | |
| Classification: | Table 5-1 - Classifications | | | |
| | Product Code | Classification
Regulation | | |
| | GCX | 21 CFR 880.6740 | Vacuum-powered Body Fluid
Suction Apparatus | |
| | HET | 21 CFR 884.1720 | Gynecologic Laparoscope and
accessories | |
| | KQT | 21 CFR 876.4370 | Gastroenterology-urology
evacuator | |
| Predicate Device: | Stryker® Cassette Pump
510(k) #: K042454
Product codes: GCX, HET, KQT | | | |
| Device Description: | The Epix Irrigation Pump (model C7000) is reusable and operates
outside of the sterile field. The Epix Suction Irrigation Tubing Set
(model C7100) is a sterile, single use device, used in conjunction with
the Epix Irrigation Pump and the house vacuum to deliver sterile
irrigation fluids and to evacuate blood, tissue debris, and smoke from
the surgical site. | | | |
| Intended Use: | The Epix Suction Irrigation System is intended as a general purpose
suction and/or irrigation device for use in laparoscopic and open
general surgery, laparoscopic and open gynecological surgery,
laparoscopic and open urologic surgery. This device delivers sterile
irrigant solution and serves as a conduit for suction. | | | |
, -
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1
Summary of Technological Characteristics:
Page 2 of (2)
The Epix® Suction Irrigation System is substantially equivalent in safety and effectiveness to the Stryker® Cassette Pump (K042454).
122619
The subject and predicate systems are technologically similar in that they are both designed to provide controlled suction from and irrigation to the operative site during laparoscopic and open procedures. For each device, the pump is capable of increasing the rate of fluid delivery and has multiple flow rate settings. The tubing set connects with IV fluid bags and the house vacuum. Suction and irrigation are actuated by the valves on the handpiece. Both systems flush blood and tissue debris from the operative site during surgery.
Discussion of Testing:
The Epix Suction Irrigation System is designed to the following safety and performance standards: IEC 60601-1 Medical electrical equipment - General requirements for safety, IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests, and ISO 10993 Biological Evaluation of Medical Devices.
Applied Medical created a testing protocol to confirm substantial equivalency between the subject and predicate. The devices were tested side-by-side to evaluate substantial equivalence in performance in a laboratory setting. The bench top tests seen in Table 5-2 were designed to focus on the functional performance of both the suction and irrigation features.
| Table 5-2 - Performance Tests | |
|---|---|
| Irrigation | Suction |
| Irrigation Fluid Flow Test | Aspiration Fluid Flow Test |
| Irrigation Fluid Leak Test | Smoke Evacuation Flow Test |
The subject device was also evaluated by a tubing collapse test based on an applicable section of ISO 10079-3 - Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source.
Conclusions Drawn from Testing:
Testing demonstrates that the subject Epix Suction Irrigation System is substantially equivalent to the predicate Stryker Cassette Pump.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized wing segments.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ОСТ
Applied Medical % Ms. Jessica Cho Regulatory Affairs Specialist 22872 Avenida Empresa Rancho Santa Margarita, California 92688
Re: K122619
Trade/Device Name: Epix® Suction Irrigation System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: BTA Dated: August 24, 2012 Received: August 28, 2012
Dear Ms. Cho:
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 Medical 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 `
2 2012
3
Page 2 - Ms. Jessica Cho
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.
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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K122 6.19
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Epix® Suction Irrigation System
Indications for Use: The Epix® Suction Irrigation System is intended as a general purpose suction and/or irrigation device for use in laparoscopic and open general surgery, laparoscopic and open gynecological surgery, and laparoscopic and open urologic surgery. This device delivers sterile irrigant solution and serves as a conduit for suction.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nil Re. Bohn for mxm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number K122619
Section 4 | INDICATIONS FOR USE STATEMENT
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