(28 days)
Not Found
No
The document describes a suction/vacuum pump system with standard mechanical and electrical components and safety features. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies. The performance studies focus on electrical safety, mechanical function, and usability, not algorithmic performance.
No
The device is described as a self-powered suction/vacuum pump intended to collect and dispose of liquid waste, primarily surgical fluids. Its function is to manage waste fluids, not to directly diagnose, cure, mitigate, treat, or prevent disease, nor does it affect the structure or any function of the body.
No
Explanation: The device is a self-powered suction/vacuum pump intended to collect and dispose of liquid waste. Its function is to manage fluids, not to diagnose medical conditions or analyze medical data for diagnostic purposes.
No
The device description clearly outlines physical hardware components including a suction/vacuum pump, fluid cart, evac station, fluid reservoirs, IV pole, and a single-use manifold. The performance studies also include testing of electrical safety, mechanical verification, and chemical resistance, which are characteristic of hardware devices.
Based on the provided information, the IntelliCartTM System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "collect and dispose of liquid waste within Hospitals, Pathology Labs, Surgical Outpatient Centers, and Doctor's Offices." This describes a device used for managing biological waste generated during medical procedures, not for performing tests on biological samples to diagnose or monitor a patient's condition.
- Device Description: The description focuses on the mechanical function of the device – a suction/vacuum pump for collecting fluids, a closed system for safety, and features like fluid reservoirs and a vacuum pump. There is no mention of analyzing or testing the collected fluids.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, DNA, pathogens, etc.)
- Providing diagnostic information
- Using reagents or assays
The IntelliCartTM System is a medical device used for fluid management and waste disposal in a clinical setting. It does not perform diagnostic testing on patient samples.
N/A
Intended Use / Indications for Use
The IntelliCart™ System is a self-powered suction/vacuum pump intended to collect and dispose of liquid waste within Hospitals, Pathology Labs, Surgical Outpatient Centers, and Doctor's Offices.
Product codes (comma separated list FDA assigned to the subject device)
JCX
Device Description
The IntelliCart™ System is a self-powered suction / vacuum pump intended to collect and dispose of liquid waste within hospitals, pathology labs, surgical outpatient centers, and doctor's offices.
The IntelliCart™ System (System) consists of a Fluid Cart (Cart) and Evac Station (Evac). Carts are mobile devices used during surgery to collect patient fluids. Evacs are stationary devices used to process and clean Carts. The System's closed design significantly reduces employee exposure to potentially infectious surgical fluids, while eliminating up to 70% of operating room red bag waste. Carts are equipped with large volume fluid reservoirs, a single regulated vacuum pump, and a height-adjustable IV pole. A single-use manifold (REF 00-5140-201-00) serves as the interface between a Cart's fluid reservoir and sterile patient suction tubing. A Cart model equipped with a bracket to hold a Smoke Evacuator is also available.
The IntelliCart™ System is a closed self-powered suction device providing various levels of suction, as selected by the user, ranging from 0-600 mmHg at maximum flow volume, and collection of up to 34L of liquid surgical waste into cart canisters equipped with a viewing window for display of canister contents shown in 100ml increments. The suction cart is portable, equipped with caster type wheels with a profile able to pass through 36 inch minimum wide doorways and allows for connection to a standard 120V/60Hz/15A facility power supply and connection to facility wall suction when necessary. Cart Canisters are integrated with a window tint feature that visually restricts canister contents during transport.
The IntelliCart™ System is operated using a back lit LCD touch screen display monitor equipped with lateral adjustment capabilities and provides digital display confirmation of total fluid capacity used as well as a functional interface for suction selection/adjustment and cart cleaning. Single use manifolds are equipped with hydrophobic filters which turn color after wash cycle is completed, giving visual indication of a manifold which must be discarded.
The Evac Station is equipped with a coupler that connects to the Suction Cart and, using compatible bleach and enzymatic solutions to break down solid waste, empties, cleans and disinfects cart canisters. After emptying and cleaning cart canisters, the Evac Station allows for draining surgical waste into facility drains.
The IntelliCart™ System can be equipped with a powered or manual IV pole, supporting up to 12,000mL of bagged fluid and allows mounting of a compatible smoke evacuation device.
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
Hospitals, Pathology Labs, Surgical Outpatient Centers, and Doctor's Offices.
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)
The following performance standards are applicable to the predicate and modified devices:
- IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. Results: Pass
- IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and Tests. Results: Pass
- IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability. Results: Pass
- ISO 10079-1 Medical suction equipment - Part 1: Electrically powered suction equipment. Results: Pass
- ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. Results: Not required - no direct or indirect patient contact.
Electrical Safety, Electromagnetic compatibility (EMC): Medical device safety testing was conducted in accordance with IEC 60601-1 standard for safety, IEC 60601-1-2 standard for EMC. Human factors were also considered in the design of the IntelliCart™ System and testing was performed in accordance with IEC 60601-1-6 and Applying Human Factors and Usability Engineering to Optimize Medical Device Design, Guidance for Industry and Food and Drug Administration Staff, February 3, 2016. Critical and essential tasks were identified as part of the studies. All identified issues were managed and mitigated to an acceptable level. The IntelliCart™ System passed all electrical safety, and electromagnetic compatibility tests to predetermined acceptance criteria.
Software and Display Verification and Validation: Software verification and validation were performed at a systems and unit level and information supplied in accordance with guidance as recommended by FDA Guidance for Industry "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". Software passed all predetermined acceptance criteria including reservoir overflow protection, cart reservoir processing and low level disinfection using validated cycles, watchdog safety transducer and safety start up warning screen.
Mechanical Verification and Validation:
Suction Performance: The IntelliCart''' System suction performance was designed and evaluated according to ISO 10079-1 Electrically powered suction equipment and as recommended by FDA "Guidance for Industry and FDA Reviewers/Staff: Guidance Document for Powered Suction Pump 510(k)s". All critical and essential tasks were identified and mitigated through risk analysis to an acceptable level.
The IntelliCart™ System was evaluated to provide adjustable vacuum pressure as measured at the manifold port to predetermined acceptance criteria to demonstrate operation capable of providing adjustable vacuum up to 12 hours of continuous use at 600mmHg.
Safety Features: The IntelliCart'" System was tested to predetermined acceptance criteria for Closed System Design, Interactive controls including de-bounce feature, Fluid Backflow Protection, Watchdog Safety Transducer, Wash Fluid leak free seals around covers and manifolds, and User Interface Vacuum Start Up Warning. The IntelliCart™ System met all predetermined acceptance criteria with passing results.
The IntelliCart™ fluid path was tested to predetermined acceptance criteria for chemical resistance against compatible enzymatic cleaners, bleach and Bactisure™. The IntelliCart™ met all predetermined acceptance criteria with passing results.
The IntelliCart™ System disposable manifold was tested to predetermined acceptance criteria to provide vacuum seal in the reservoir when installed. The IntelliCart™ met all acceptance criteria with passing results.
IV Pole Function and Support: Manual and Power IV Poles were tested to predetermined acceptance criteria for maximum bagged fluid support and automatic function (power IV pole only). The IntelliCart™ met all acceptance criteria with passing results.
Outer Body Shell and Fluid Capacity: The IntelliCart™ was tested to predetermined acceptance criteria for portability using casters and brakes including profile requirements to pass through standard 36″ door thresholds. The IntelliCart''' met all acceptance criteria with passing results.
IntelliCart™ was tested to predetermined acceptance criteria to include directly viewable fluid measurements, easily viewable touchscreen monitor and exterior surfaces which provide chemical resistance to standard hospital wipes. The IntelliCart™ met all acceptance criteria with passing results.
Fluid Reservoir Concealment: ConSeal™ technology providing concealment of canister contents was evaluated to predetermined acceptance criteria for the concealment of collected waste fluid. The IntelliCart'10 met all acceptance criteria with passing results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 878.4780 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
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1
Image /page/1/Picture/0 description: The image shows the logo for Dornoch Medical Systems, Inc. The word "Dornoch" is written in a sans-serif font, with the "O" in "Dornoch" being a dark red color, while the rest of the letters are a light gray color. Below the word "Dornoch" is the text "Medical Systems, Inc." in a smaller font size and light gray color. The logo is simple and modern, and the use of color helps to draw attention to the company's name.
K190789 510(k) Summary
| 510(k)
Summary | Sponsor: | Dornoch Medical Systems, Inc.
200 North West Parkway
Riverside, MO 64150
Establishment Registration Number: 1954182 |
|-------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact: | Michael T. Wolford
Regulatory Affairs Associate Manager
Phone: (330) 364-9411 |
| | Date: | 02/08/2019 |
| | Trade Name: | IntelliCart™ System |
| | FDA Product
Code/Device | JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered |
| | Common Name:
Regulation Number
and Description;
Device Classification: | 21 CFR 878.4780 – Powered suction pump; Class II |
| | Predicate Device | IntelliCart™ System (K172481) |
| | Device Description | The IntelliCart™ System is a self-powered suction / vacuum pump intended
to collect and dispose of liquid waste within hospitals, pathology labs,
surgical outpatient centers, and doctor's offices. |
| | | The IntelliCart™ System (System) consists of a Fluid Cart (Cart) and Evac
Station (Evac). |
| | | Carts are mobile devices used during surgery to collect patient fluids. Evacs
are stationary devices used to process and clean Carts. The System's closed
design significantly reduces employee exposure to potentially infectious
surgical fluids, while eliminating up to 70% of operating room red bag
waste. |
| | | Carts are equipped with large volume fluid reservoirs, a single regulated
vacuum pump, and a height-adjustable IV pole. A single-use manifold (REF
00-5140-201-00) serves as the interface between a Cart's fluid reservoir and
sterile patient suction tubing. A Cart model equipped with a bracket to hold
a Smoke Evacuator is also available. |
| | | The IntelliCart™ System is a closed self-powered suction device providing
various levels of suction, as selected by the user, ranging from 0-600
mmHg at maximum flow volume, and collection of up to 34L of liquid
surgical waste into cart canisters equipped with a viewing window for
display of canister contents shown in 100ml increments. |
2
The suction cart is portable, equipped with caster type wheels with a profile able to pass through 36 inch minimum wide doorways and allows for connection to a standard 120V/60Hz/15A facility power supply and connection to facility wall suction when necessary. Cart Canisters are integrated with a window tint feature that visually restricts canister contents during transport.
The IntelliCart™ System is operated using a back lit LCD touch screen display monitor equipped with lateral adjustment capabilities and provides digital display confirmation of total fluid capacity used as well as a functional interface for suction selection/adjustment and cart cleaning.
Single use manifolds are equipped with hydrophobic filters which turn color after wash cycle is completed, giving visual indication of a manifold which must be discarded.
The Evac Station is equipped with a coupler that connects to the Suction Cart and, using compatible bleach and enzymatic solutions to break down solid waste, empties, cleans and disinfects cart canisters. After emptying and cleaning cart canisters, the Evac Station allows for draining surgical waste into facility drains.
The IntelliCart™ System can be equipped with a powered or manual IV pole, supporting up to 12,000mL of bagged fluid and allows mounting of a compatible smoke evacuation device.
Indications for Use The IntelliCartTM System is a self-powered suction/vacuum pump intended to collect and dispose of liquid waste within Hospitals, Pathology Labs, Surgical Outpatient Centers, and Doctor's Offices.
Technological Characteristics Comparison:
The following tables provide a comparison between the predicate device showing similarities and differences:
3
Image /page/3/Picture/0 description: The image shows the logo for Dornoch Medical Systems, Inc. The word "Dornoch" is written in a sans-serif font, with the "O" in a dark red color and the rest of the letters in a light gray. Below the word "Dornoch" is the text "Medical Systems, Inc." in a smaller, light gray font. The logo has a clean and modern design.
System Use
| Property | Predicate Device ( IntelliCart™ System
(K172481) | K190789 (IntelliCart™ System) |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Intended Use | The IntelliCart™ System is a self-powered
suction/vacuum pump intended to collect and
dispose of liquid waste within Hospitals,
Pathology Labs, Surgical Outpatient Centers,
and Doctor's Offices. | Same |
| Single Use or
Reusable | Cart, Evac – Reusable
Manifold, Single Use | Same |
| Target
Population | Ward Use, General Surgical Application | Same |
System Operating Principle
| Property | Predicate Device (IntelliCart™ System (K172481) | K190789 (IntelliCart™ System) |
|---|---|---|
| Display | LCD, Backlit Touch | Same |
| Suction/Exhaust | Closed suction system with variable suction levels based | |
| on user selection providing regulated vacuum from 0- | ||
| 600mmHg using AC powered twin piston vacuum pump | ||
| passing through single use manifolds and into canisters. | Same | |
| Filtration | HEPA Filtration 99.97% | Same |
| Cleaning | Cart Canister Processing using automated validated cycle | |
| to low level disinfection | Same | |
| Manifold | Single Use, disposable manifold with Hydrophobic Filter | Same |
| Software | Validated Software | Same |
| Electrical | ||
| Requirements | (Cart) 120VAC, 60Hz, 4.75amp | |
| (Evac) Same | Same | |
| Portable | Locking casters and push handle allow cart to be easily | |
| moved | Same | |
| Property | Predicate Device (IntelliCart™ System (K172481) | K190789 (IntelliCart™ System) |
| Materials | No direct or indirect patient contact | Same |
| Touch Screen | LCD backlit color touch screen display | Same |
| Total Fluid | ||
| Capacity | 34L | Same |
| Single Use | ||
| Manifold | Manifold hydrophobic filter turns blue after use, | |
| indicating it must be replaced | Same | |
| Suction Range | 0-600mmHg | Same |
| Footprint | 55"H x 23.5"W x 23"D | Same |
| Safety Alert | Audible and visual display for early warning of overflow | |
| protection system and vacuum start up alert | Same | |
| Compatible with | ||
| Wall Suction | Yes | Same |
| ConSeal™ Tint | Yes | Same |
| Canister Exterior | ||
| Graduations | Graduations marked on canister exterior provide | |
| approximate visual indication of contents in 100mL | ||
| increments. | Same | |
| IV Pole | Carts available with powered or manual IV pole, capable | |
| of 12,000mL maximum fluid capacity | Same | |
| External Mounting | ||
| of compatible | ||
| smoke evacuation | Yes | Same |
| HEPA Filtration | 99.97% | Same |
| Cleaning | Multiple user selected Enzymatic and Bleach cleaning | |
| cycles from 3-12 minutes | Same | |
| Safety Features | ||
| Feature | Predicate Device (IntelliCart™ System (K172481) | K190789 (IntelliCart™ System) |
| Closed System | ||
| Design | Confine and contain fluids during collection and disposal | Same |
| Interactive | ||
| Controls | Graphical User Interface (GUI) guides user through | |
| system operation | Same | |
| Bleach Cycle | ||
| Monitoring | Continuous automatic monitoring of bleach cycle using | |
| electronic sensors | Same | |
| Fluid Backflow | ||
| Protection | Positive air gap maintained between collected fluids and | |
| single-use Manifolds | Same | |
| Vacuum System | ||
| Protection | Hydrophobic filters shut off vacuum supply when wet, | |
| preventing liquids from contaminating the Cart vacuum | ||
| supply | Same | |
| Air Exhaust | ||
| Protection | Replaceable HEPA rated filter | Same |
| Overflow | ||
| Protection | Warning to alert user when reservoir is 3000mL and | |
| 1500mL from full capacity – automatic shut off when | ||
| canisters have reached full capacity | Same | |
| ES 60601-1 | ||
| Classification | Class 1, Type B applied part (suction tubing - not supplied | |
| by Zimmer Biomet) | Same |
4
5
Image /page/5/Picture/0 description: The image shows the logo for Dornoch Medical Systems, Inc. The word "Dornoch" is written in a sans-serif font, with the "O" in "Dornoch" being a dark red color, while the rest of the letters are a light gray color. Below the word "Dornoch" is the text "Medical Systems, Inc." in a smaller, light gray font.
Summary of Non-Clinical Performance Data
The following performance standards are applicable to the predicate and modified devices:
| | Predetermined
Acceptance
Criteria | Results | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|--------------------------------------------------------|--------------------------------------|
| Standard or Test Type | | Predicate Device
(IntelliCartTM
System (K172481) | K190789
(IntelliCartTM
System) |
| IEC 60601-1 Medical electrical equipment - Part
1: General requirements for basic safety and
essential performance | Yes | Pass | Pass |
| IEC 60601-1-2 Medical electrical equipment -
Part 1-2: General requirements for basic safety
and essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements
and Tests | Yes | Pass | Pass |
| IEC 60601-1-6 Medical electrical equipment -
Part 1-6: General requirements for basic safety
and essential performance - Collateral standard:
Usability | Yes | Pass | Pass |
| ISO 10079-1 Medical suction equipment - Part
1: Electrically powered suction equipment | Yes | Pass | Pass |
| ISO 10993-1 Biological evaluation of medical
devices - Part 1: Evaluation and testing within a
risk management process | Not required - no
direct or indirect
patient contact | N/A | N/A |
Electrical Safety, Electromagnetic compatibility (EMC)
Medical device safety testing was conducted in accordance with IEC 60601-1 standard for safety, IEC 60601-1-2 standard for EMC. Human factors were also considered in the design of the IntelliCart™ System and testing was performed in accordance with IEC 60601-1-6 and Applying
6
Image /page/6/Picture/0 description: The image shows the logo for Dornoch Medical Systems, Inc. The word "Dornoch" is written in a sans-serif font, with the "O" in a dark red color and the rest of the letters in a light gray color. Below the word "Dornoch" is the text "Medical Systems, Inc." in a smaller, light gray font.
Human Factors and Usability Engineering to Optimize Medical Device Design, Guidance for Industry and Food and Drug Administration Staff, February 3, 2016. Critical and essential tasks were identified as part of the studies. All identified issues were managed and mitigated to an acceptable level. The IntelliCart™ System passed all electrical safety, and electromagnetic compatibility tests to predetermined acceptance criteria.
Software and Display Verification and Validation
Software verification and validation were performed at a systems and unit level and information supplied in accordance with guidance as recommended by FDA Guidance for Industry "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". Software passed all predetermined acceptance criteria including reservoir overflow protection, cart reservoir processing and low level disinfection using validated cycles, watchdog safety transducer and safety start up warning screen.
Mechanical Verification and Validation
Suction Performance
The IntelliCart'''' System suction performance was designed and evaluated according to ISO 10079-1 Electrically powered suction equipment and as recommended by FDA "Guidance for Industry and FDA Reviewers/Staff: Guidance Document for Powered Suction Pump 510(k)s". All critical and essential tasks were identified and mitigated through risk analysis to an acceptable level.
The IntelliCart™ System was evaluated to provide adjustable vacuum pressure as measured at the manifold port to predetermined acceptance criteria to demonstrate operation capable of providing adjustable vacuum up to 12 hours of continuous use at 600mmHg.
Safety Features
The IntelliCart'" System was tested to predetermined acceptance criteria for Closed System Design, Interactive controls including de-bounce feature, Fluid Backflow Protection, Watchdog Safety Transducer, Wash Fluid leak free seals around covers and manifolds, and User Interface Vacuum Start Up Warning. The IntelliCart™ System met all predetermined acceptance criteria with passing results.
The IntelliCart™ fluid path was tested to predetermined acceptance criteria for chemical resistance against compatible enzymatic cleaners, bleach and Bactisure™. The IntelliCart™ met all predetermined acceptance criteria with passing results.
The IntelliCart™ System disposable manifold was tested to predetermined acceptance criteria to provide vacuum seal in the reservoir when installed. The IntelliCart™ met all acceptance criteria with passing results.
7
Image /page/7/Picture/0 description: The image shows the logo for Dornoch Medical Systems, Inc. The word "Dornoch" is written in a sans-serif font, with the "O" in red and the rest of the letters in gray. Below the word "Dornoch" is the text "Medical Systems, Inc." in a smaller font.
IV Pole Function and Support
Manual and Power IV Poles were tested to predetermined acceptance criteria for maximum bagged fluid support and automatic function (power IV pole only). The IntelliCart™ met all acceptance criteria with passing results.
Outer Body Shell and Fluid Capacity
The IntelliCart™ was tested to predetermined acceptance criteria for portability using casters and brakes including profile requirements to pass through standard 36″ door thresholds. The IntelliCart''' met all acceptance criteria with passing results.
IntelliCart™ was tested to predetermined acceptance criteria to include directly viewable fluid measurements, easily viewable touchscreen monitor and exterior surfaces which provide chemical resistance to standard hospital wipes. The IntelliCart™ met all acceptance criteria with passing results.
Fluid Reservoir Concealment
ConSeal™ technology providing concealment of canister contents was evaluated to predetermined acceptance criteria for the concealment of collected waste fluid. The IntelliCart'10 met all acceptance criteria with passing results.
Conclusion
Based on the intended uses, technological characteristics and non-clinical performance data, the
subject device is as safe, as effective, and performs as well as or better than the legally marketed
predicate device (K172481), Class II (21 CFR 878.4780), product code JCX.
8
Image /page/8/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 24, 2019
Dornoch Medical Systems Michael Wolford Regulatory Affairs Associate Manager 200 North West Parkway Riverside, Missouri 64150
Re: K190789
Trade/Device Name: IntelliCart™ System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: JCX Dated: February 6, 2019 Received: March 27, 2019
Dear Michael Wolford:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
9
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control. and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure