(304 days)
Not Found
No
The device description focuses on mechanical and elastomeric components for controlled drug delivery, with no mention of AI/ML algorithms for decision-making, analysis, or control.
Yes
The device is intended to deliver medication for pain management and regional anesthesia, which are therapeutic interventions.
No
Explanation: The device is intended for the continuous delivery of medication for pain management and regional anesthesia, not for diagnosing medical conditions.
No
The device description explicitly states it consists of an "elastomeric pressure source (i.e. elastomeric pump)" and an "integrated administration set/line," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver medication (local anesthetics) to or around surgical wound sites and nerves for pain management. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a pump designed to deliver fluids. It does not involve the examination of specimens derived from the human body for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to perform tests on samples like blood, urine, or tissue to diagnose diseases or conditions. The ON-Q* Pump is a drug delivery system.
N/A
Intended Use / Indications for Use
ON-Q* Pump is intended to provide continuous delivery of medication (such as local anesthetics) to or around surgical wound sites and/or close proximity to nerves for preoperative and postoperative regional anesthesia and/or pain management. Routes of administration include: intraoperative site, peripheral nerve block, percutaneous and epidural.
ON-Q* Pump is indicated to significantly decrease pain and narcotic use when used to deliver local anesthetics to or around surgical wound sites, or close proximity to nerves, when compared to narcotic only pain management.
ON-Q* Pump with Bolus device is intended for users 18 years of age and older.
Product codes (comma separated list FDA assigned to the subject device)
MEB
Device Description
The ON-Q* Pump with Bolus consists of an elastomeric pressure source (i.e. elastomeric pump) with an integrated administration set/line. The ON-Q* Pump with Bolus delivers continuous infusion (basal) and allows incremental fixed-volume boluses to be delivered on demand by the patient. In addition to the optional bolus component, the administration line may contain any of the following optional components:
- Filter
- Select-A-Flow variable flow rate assembly ●
- Y-adaptor ●
The bolus component controls the bolus and/or basal flow rate capability of the administration set that connects to the elastomeric pump. The bolus component is an integrated part of the pump system and cannot be used alone. The patient or healthcare provider presses a button to activate bolus delivery. The refill time determines the patient must wait prior to receiving another full bolus dose.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgical wound sites and/or close proximity to nerves
Indicated Patient Age Range
18 years of age and older
Intended User / Care Setting
User Population: This device is used by pharmacists for pump filling only, by clinicians, Nurses) for placement, infusion and adjustment of flow rate and by patients 18 years of age or older for adjustment of flow rate or activation of bolus.
Use Environment: The ON-Q * elastomeric pumps are suitable for use as an ambulatory device in hospitals, home environments or alternative care sites as directed by the healthcare professional.
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)
Performance Testing:
The following bench testing was performed and reviewed to support the substantial equivalence of the subject device:
- Performance Verification ●
- Bolus refill time/dispensed volume o
- Bolus flow rate о
- Bolus deployment force O
- Bolus lifecycle testing O
- O Bolus pressure (leak) test
- Design Validation and Human Factors Evaluation ●
- Packaging Verification
- Sterilization Verification ●
- Biocompatibility, external communicating with indirect blood path contact for prolonged duration (>24 hours to
§ 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).
0
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
March 22, 2019
Halyard Health % Neerav Parikh Technical Leader, Regulatory Affairs AVANOS 43 Discovery, Suite 100 Irvine, California 92618
Re: K181360
Trade/Device Name: ON-Q* Pump with Bolus Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: MEB Dated: February 22, 2019 Received: February 22, 2019
Dear Neerav Parikh:
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
1
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 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 mediation-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,
Image /page/1/Picture/5 description: The image shows the name "Carolyn C. Dorgan -S" in large, bold font on the left side of the image. On the right side of the image, there is a digital signature that reads "Digitally signed by Carolyn C. Dorgan -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1-2001800814, cn=Carolyn C. Dorgan -S Date: 2019.03.22 14:09:14-04'00'".
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
2
Indications for Use
510(k) Number (if known) K181360
Device Name ON-Q* Pump with Bolus
Indications for Use (Describe)
ON-Q* Pump is intended to provide continuous delivery of medication (such as local anesthetics) to or around surgical wound sites and/or close proximity to nerves for preoperative and postoperative regional anesthesia and/or pain management. Routes of administration include: intraoperative site, peripheral nerve block, percutaneous and epidural.
ON-Q* Pump is indicated to significantly decrease pain and narcotic use when used to deliver local anesthetics to or around surgical wound sites, or close proximity to nerves, when compared to narcotic only pain management.
ON-Q* Pump with Bolus device is intended for users 18 years of age and older.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K181360 510(K) SUMMARY
| Preparation Date: | March 22, 2019 |
|---|---|
| Manufacturer's Name: | AVANOS Medical Inc. |
| 43 Discovery, Suite 100, Irvine, CA 92618 | |
| Corresponding Officials: | Neerav Parikh |
| Technical Leader, Regulatory Affairs | |
| Telephone Number: | (949) 923-2331 |
| E-mail Address: | Neerav.Parikh@avanos.com |
| Nazanin Yacobi, PhD | |
| Associate Director, Regulatory Affairs | |
| Telephone Number: | (949) 923-2323 |
| E-mail Address: | Nazanin.Yacobi@avanos.com |
| Trade Name: | ON-Q* Pump with Bolus |
| Common or Usual Name: | Pump, Infusion, Elastomeric |
| Regulation Name: | Infusion Pump |
| Regulation Number: | 21 CFR 880.5725 |
| Product Code: | MEB |
| Device Class: | Class II |
| Primary Predicate Device: | K063530, ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP |
Device Description
The ON-Q* Pump with Bolus consists of an elastomeric pressure source (i.e. elastomeric pump) with an integrated administration set/line. The ON-Q* Pump with Bolus delivers continuous infusion (basal) and allows incremental fixedvolume boluses to be delivered on demand by the patient. In addition to the optional bolus component, the administration line may contain any of the following optional components:
- Filter
- Select-A-Flow variable flow rate assembly ●
- Y-adaptor ●
The bolus component controls the bolus and/or basal flow rate capability of the administration set that connects to the elastomeric pump. The bolus component is an integrated part of the pump system and cannot be used alone. The patient or healthcare provider presses a button to activate bolus delivery. The refill time determines the patient must wait prior to receiving another full bolus dose.
4
Indications for Use
ON-Q* Pump is intended to provide continuous delivery of medication (such as local anesthetics) to or around surgical wound sites and/or close proximity to nerves for preoperative and postoperative regional anesthesia and/or pain management. Routes of administration include: intraoperative site, peripheral nerve block, percutaneous and epidural.
ON-O* Pump is indicated to significantly decrease pain and narcotic use when used to deliver local anesthetics to or around surgical wound sites, or close proximity to nerves, when compared to narcotic only pain management.
ON-Q* Pump with Bolus device is intended for users 18 years of age and older.
The device is intended for prescription use only.
User Population
This device is used by pharmacists for pump filling only, by clinicians, Nurses) for placement, infusion and adjustment of flow rate and by patients 18 years of age or older for adjustment of flow rate or activation of bolus.
Use Environment
The ON-Q * elastomeric pumps are suitable for use as an ambulatory device in hospitals, home environments or alternative care sites as directed by the healthcare professional.
Substantial Equivalence Discussion
Intended Use Comparison
The table below includes a comparison of the intended use between the new device and those of the predicate device:
| Characteristic | Predicate Device | Subject Device | |
|---|---|---|---|
| K063530 | K181360 | ||
| Indications for Use | The ON-Q* Pump is intended for continuous | ||
| and/or intermittent delivery of medication | |||
| (such as local anesthetics or narcotics) to or | |||
| around surgical wound sites and/or close | |||
| proximity to nerves for preoperative, | |||
| perioperative and postoperative regional | |||
| anesthesia and pain management. Routes of | |||
| administration may be intraoperative, | |||
| perineural, percutaneous and epidural. | |||
| The ON-Q* Pump is also intended to | |||
| significantly decrease narcotic use and pain | |||
| when used to deliver local anesthetics to or | |||
| around surgical wound sites or close proximity | |||
| to nerves when compared with narcotic only | |||
| pain management. | ON-Q* Pump is intended to provide | ||
| continuous delivery of medication (such as | |||
| local anesthetics) to or around surgical wound | |||
| sites and/or close proximity to nerves for | |||
| preoperative, perioperative and postoperative | |||
| regional anesthesia and/or pain management. | |||
| Routes of administration include: | |||
| intraoperative site, peripheral nerve block, | |||
| percutaneous and epidural. | |||
| ON-Q* Pump is indicated to significantly | |||
| decrease pain and narcotic use when used to | |||
| deliver local anesthetics to or around surgical | |||
| wound sites, or close proximity to nerves, | |||
| when compared to narcotic only pain | |||
| management. | |||
| ON-Q* Pump with Bolus device is intended | |||
| for users 18 years of age and older. | |||
| Prescription Only or | |||
| Over the Counter | Prescription Only | Prescription Only | |
| Intended Population | This device is used by pharmacists for pump | ||
| filling only, by clinicians (Physicians, Nurses) | This device is used by pharmacists for pump | ||
| filling only, by clinicians (Physicians, Nurses) |
5
| Characteristic | Predicate Device
K063530 | Subject Device
K181360 |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | for placement, infusion and adjustment of flow
rate and by patients for adjustment of flow rate
or activation of bolus. | for placement, infusion and adjustment of flow
rate and by patients 18 years of age or older for
adjustment of flow rate or activation of bolus. |
| Environment of Use | The ON-Q* elastomeric pumps are suitable for
use as an ambulatory device in hospitals, home
environments or alternative care sites as
directed by the healthcare professional. | The ON-Q* elastomeric pumps are suitable for
use as an ambulatory device in hospitals, home
environments or alternative care sites as
directed by the healthcare professional. |
Discussions of differences in Indications for Use statement
Differences in the indications for use statement provide further clarification.
Discussions of differences in intended population
The difference in patient population was validated through summative human factors studies.
Discussions of differences in environment of use
The environment of use for the subject device is identical to the predicate device.
Technological Characteristics
The table below includes a comparison of the technological characteristics between the new device and those of the predicate device:
| Technological
Characteristic | Predicate Device
K063530 | Subject Device
K181360 | Comments |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Operating Principle
Pump: | The elastomeric bladders function as
the fluid reservoir and the pressure
source. The pressure that pumps the
fluid comes from the strain energy of
the elastomeric properties of the
bladder that is forced to expand when
the pump is filled. | The elastomeric bladders function as
the fluid reservoir and the pressure
source. The pressure that pumps the
fluid comes from the strain energy of
the elastomeric properties of the
bladder that is forced to expand when
the pump is filled. | Same |
| Operating Principle
Bolus: | Manual activation, depression of
bolus delivery button, by the user is
required to deliver the on-demand
bolus of medication. | Manual activation, depression of
bolus delivery button, by the user is
required to deliver the on-demand
bolus of medication. | Same |
| Control Mechanism
Pump: | Mechanical force from an elastomeric
bladder with a physical flow restrictor | Mechanical force from an elastomeric
bladder with a physical flow restrictor | Same |
| Control Mechanism
Bolus: | Mechanical force from an internal
spring with a physical flow restrictor | Mechanical force from an elastomeric
bladder with a physical flow restrictor | See Comment
#1 |
| Energy Type | Elastomeric force (Mechanical) | Elastomeric force (Mechanical) | Same |
| Technological
Characteristic | Predicate Device
K063530 | Subject Device
K181360 | Comments |
| Specifications | | | |
| Pump Fill Volume: | 50 to 770 mL with fixed and variable
flow rate configurations ranging from
0.5 to 250 mL/hour to 1 to 3 delivery
sites | 50 to 770 mL with fixed and variable
flow rate configurations ranging from
0.5 to 250 mL/hour to 1 to 3 delivery
sites | Same |
| Bolus Fill Volume: | 5 mL bolus dose with 60 minute refill
5 mL bolus dose with 30 minute refill | 3 mL bolus dose with 30 minute refill
3 mL bolus dose with 20 minute refill | See Comment
#2 |
| Material | | | |
| Pump | Acrylonitrile butadiene (ABS),
silicone, Kraton, Latex, Ethylene
Propylene, High Density
Polyethylene (HDPE), Polyvinyl
Chloride (PVC), Di(2-ethylhexhyl)
phthalate (DEHP) Plasticizer | Acrylonitrile butadiene (ABS),
silicone, Kraton, Latex, Ethylene
Propylene, High Density
Polyethylene (HDPE), Polyvinyl
Chloride (PVC), Di(2-ethylhexhyl)
phthalate (DEHP) Plasticizer | Same |
| Bolus | Silicone, PVC, polycarbonate | ABS, Silicone, stainless steel | See Comment
#3 |
| Biocompatibility | Biocompatible per ISO 10993 | Biocompatible per ISO 10993 | Same |
| Sterilization | Sterile per ISO-11135 via ethylene
oxide (EO), single use | Sterile per ISO-11135 via ethylene
oxide (EO), single use | Same |
| | EO Residuals per ISO 10993-7 | EO Residuals per ISO 10993-7 | Same |
| | Sterility Assurance Level (SAL) 10-6 | Sterility Assurance Level (SAL) 10-6 | Same |
| Packaging | Chevron-style Tyvek Pouch | Chevron-style Tyvek Pouch | Same |
| | Conform to the requirements of ISO
11607 | Conform to the requirements of ISO
11607 | Same |
| Shelf Life | 2.5 years | 2 years | See Comment
#4 |
6
Discussions of differences in technological characteristics
Comment 1
The bolus controller of the subject device is driven by an elastomeric bladder instead of an internal spring like the predicate. However, bolus controller performance of the subject device was verified to ensure it reliably met performance requirements (See Comment #2). Therefore, the difference in control mechanism does not raise different questions of safety and effectiveness.
Comment 2
The bolus fill volume specifications are within the range of the predicate bolus fill volume. Since the types of medication delivered and routes of administration are unchanged, the change in specification does not raise different questions of safety and effectiveness.
Comment 3
The materials of construction of the bolus controller changed to ABS, Silicone, stainless steel. However, the contact category and duration of contact are unchanged between the subject and predicate device. In addition, biocompatibility
7
testing was provided to support the use of the new materials for the bolus controller. Therefore, the change does not raise different questions of safety and effectiveness.
Comment 4
The shelf life of the subject device was reduced from 2.5 years compared to the predicate. Sterilization and device performance data was provided to support the 2 year shelf life and additional testing is ongoing to support expanded shelf life labeling. Therefore, the differences in shelf life does not raise different questions of safety and effectiveness.
Performance Testing
The following bench testing was performed and reviewed to support the substantial equivalence of the subject device:
- Performance Verification ●
- Bolus refill time/dispensed volume o
- Bolus flow rate о
- Bolus deployment force O
- Bolus lifecycle testing O
- O Bolus pressure (leak) test
- Design Validation and Human Factors Evaluation ●
- Packaging Verification
- Sterilization Verification ●
- Biocompatibility, external communicating with indirect blood path contact for prolonged duration (>24 hours to