(132 days)
Not Found
No
The device description explicitly states it is a mechanically-driven pump and there is no mention of AI, ML, or any computational processing in the provided text.
Yes
The device is described as an infusion device intended to provide continuous infusion of medication, such as local anesthetics or corticosteroids, directly into a target site for the purpose of pain relief and postoperative pain management. This directly indicates a therapeutic purpose.
No
The device is described as an infusion pump for continuous delivery of medication for pain relief, not for diagnosing conditions.
No
The device description clearly describes a mechanically-driven infusion pump with a syringe-like reservoir and spring, indicating it is a hardware device for delivering medication. There is no mention of software as the primary or sole component.
Based on the provided information, the Sgarlato PainFree Pump is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to infuse medication directly into a target site for pain relief. This is a therapeutic application, not a diagnostic one. IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a mechanical pump for delivering liquid medication. This aligns with a therapeutic device, not a diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD testing.
Therefore, the Sgarlato PainFree Pump is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Sgarlato PainFree Pump is a single use, general purpose infusion device intended to provide continuous infusion of medication (such as local anesthetics or corticosteroids) directly into a target site for the purpose of pain relief. Infusion may be carried out via percutaneous, subcutaneous, and epidural routes. The PainFree Pump may be used to provide continuous infusion of a local anesthetic directly into an intraoperative site for postoperative management of pain following surgery. It is suitable for use as an ambulatory device. It is not intended for vascular drug delivery, hyperalimentation, or the delivery of blood or blood products.
Product codes (comma separated list FDA assigned to the subject device)
FRN
Device Description
The Sgarlato PainFree pump is mechanically the same device currently legally marketed by Sgarlato Labs for continuous infusion of liquid medication into an intraoperative site for postoperative pain management. Similar mechanically-driven, infusion pumps with the same flow and reservoir capacity include percutaneous, subcutaneous, intramuscular and epidural infusion sites as alternative routes for administration of medication. Because the Sgarlato PainFree pump offers equivalent flow rates, similar reservoir volumes, and similar materials in its construction, Sqarlato laboratories believes that its use with alternative administration routes should be considered substantially equivalent to currently cleared predicate devices. Predicate Devices cited are the Paragon Infusion Kit K984146 and the Sgarlato Pain Control Infusion Pump K990101.
This infusion pump is one of a multiplicity of similar general purpose devices marketed to provide continuous infusion of moderate amounts of liquid medication (100-200 ml) over an extended period of time without use of electrical power. These mechanically-driven, single-use or reusable infusion pumps are therefore suitable for ambulatory use and can provide medication infusion via catheters for extended periods ranging from a few hours to several days.
The PainFree pump is intended to infuse liquid medications such as corticosteroids or other anti-inflammatory compounds of the same approximate density of local anesthetics. Compounds such as blood or lipids that may clog the medication filter included in the set are not intended to be used. The original the modion Control Infusion pump was primarily used for infusing local anesthetics.
The PainFree pump uses a syringe-like reservoir that compresses the plunger against a self-contained spring to apply pressure to the liquid volume in the syringe. The Sgarlato device is distributed as a single-use sterile device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoperative site, target site
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
§ 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
MAR 3 0 2005
SECTION E - 510(k) Summary for the Sgarlato PainFree pump
General
The Sgarlato PainFree pump is mechanically the same device currently legally marketed by Sgarlato Labs for continuous infusion of liquid medication into an intraoperative site for postoperative pain management. Similar mechanicallydriven, infusion pumps with the same flow and reservoir capacity include percutaneous, subcutaneous, intramuscular and epidural infusion sites as alternative routes for administration of medication. Because the Sgarlato PainFree pump offers equivalent flow rates, similar reservoir volumes, and similar materials in its construction, Sqarlato laboratories believes that its use with alternative administration routes should be considered substantially equivalent to currently cleared predicate devices. Predicate Devices cited are the Paragon Infusion Kit K984146 and the Sgarlato Pain Control Infusion Pump K990101.
Similarities
This infusion pump is one of a multiplicity of similar general purpose devices marketed to provide continuous infusion of moderate amounts of liquid medication (100-200 ml) over an extended period of time without use of electrical power. These mechanically-driven, single-use or reusable infusion pumps are therefore suitable for ambulatory use and can provide medication infusion via catheters for extended periods ranging from a few hours to several days.
The Predicate Devices, the I-Flow Paragon Infusion Kit (K984146) and the Sgarlato Pain Control Infusion Pump (K990101) offer similar flow rates and reservoir capacities. They both are mechanical devices that use spring energy to provide pressurized medication. They use micro-bore flow restrictors to meter the flow from a pressure vessel to the desired at the infusion site. They both include epidural-style medication catheters for delivery of medication to the site and offer the ability to easily exchange flow restrictors in a given setting. They offer y adapters to split the reservoir volume to multiple sites in a given surgical setting. They provide convenience kits with a filling syringe, needle introducer for the catheter, and various accessories to affix the catheter to the patient, label and carry the pump, etc. Neither device is intended for use in delivering blood, blood product, lipids, or for other intravenous or TPN use.
Differences
The primary difference between the original Sqarlato Pain Control Infusion Pump K990101) and the Sgarlato PainFree pump is expansion of the sites indicated for infusion. The original device listed percutaneous infusion via a catheter to an intraoperative site. The extended indication adds subcutaneous, and epidural sites.
1
The PainFree pump is intended to infuse liquid medications such as corticosteroids or other anti-inflammatory compounds of the same approximate density of local anesthetics. Compounds such as blood or lipids that may clog the medication filter included in the set are not intended to be used. The original the modion Control Infusion pump was primarily used for infusing local anesthetics.
The primary difference between the I-Flow pump and the PainFree pump is the method of pressurizing the reservoir. The I-Flow device uses a spring/scissors mechanism to apply pressure to a pliable drug bag within a hard shell. The PainFree pump uses a syringe-like reservoir that compresses the plunger against a self-contained spring to apply pressure to the liquid volume in the syringe. The Sgarlato device is distributed as a single-use sterile device. The I-Flow device may be reused and/or sterilized by the user.
Conclusion
The PainFree pump is substantially equivalent mechanically to its predecessor Pain Control Infusion Pump from Sgarlato. The PainFree pump is substantially equivalent in terms of identified infusion sites to the I-Flow Paragon device. See Table 1 for more specific information.
2
| | Paragon Infusion Kit
(K984146) | Sgarlato PCIP
(K896422) | Sgarlato PainFree
Pump (review item) |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | | | |
| Intended Use | Continuous infusion of
medication into an
intraoperative site for
general surgery and
pain management.
The pump itself is for
general infusion use. | Continuous infusion of
local anesthetic into a
surgical site for
postoperative pain
management | Continuous infusion of
medication into a
target site for pain
management |
| Routes of
Administration | Percutaneous,
subcutaneous,
intramuscular, and
epidural | Percutaneous | Percutaneous,
subcutaneous, and
epidural |
| Contraindications | Not for intravenous
delivery. Not intended
for blood, blood
products, lipids, or fat
emulsions | Not for epidural,
subcutaneous, or
vascular drug
delivery. Not for
delivery of blood,
blood products, or
TPN | Not for intravenous
delivery. Not intended
for blood, blood
products, lipids, or fat
emulsions |
| Reuse | Re-usable pump,
single use
administration sets | Single Use | Single Use |
| Fill Volumes | 100 ml | 100 or 200 ml | 100 or 200 ml |
| Flow Rates | 0.5,1,2,4, or 10 ml/hr | 0.5,1,or 2 ml/hr | 1,2, or 4 ml/hr |
| Flow control | Micro-bore tubing with
medication filter | Micro-bore tubing with
5 micron medication
filter | Micro-bore tubing with
5 micron medication
filter |
| Pump Mechanism | Spring-scissors plate
compressing PVC bag | Spring-powered
syringe plunger | Spring-powered
syringe plunger |
| Power | Compressed spring | Compressed spring | Compressed spring |
| Components and
Materials | Conform with ISO
10993 part 1 for fluid
path | Conform with ISO
10993 part 1 for fluid
path | Conform with ISO
10993 part 1 for fluid
path |
| Safety/Alarms | None except Fluid
level indicator to
monitor flow | None except plunger
movement monitors
flow | None except plunger
movement monitors
flow |
| Packaging | Tyvek-sealed tray
containing pump,
administration sets,
and accessories.
Flow restrictors, and
y- connector sets,
may be separately
packaged | Tyvek-sealed tray
containing pump,
administration sets,
and accessories.
Flow restrictors, and y
connector sets, may
be separately
packaged | Tyvek-sealed tray
containing pump,
administration sets,
and accessories.
Flow restrictors, y-
connector sets, and
catheter sets may be
separately packaged |
Comparison to legally marketed Devices
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized representation of a human figure, composed of three overlapping profiles, with the arms raised.
MAR 3 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sgarlato Laboratories, Incorporated C/O Michael McDougall, Ph.D. Regulatory Affairs Michann Partners LLC 2315 South Bascom Avenue Suite #200 Campbell, California 95008
Re: K043204
Ro4920 |
Trade/Device Name: Sgarlato PainFree Pump; Sgarlato Pain Control Infusion Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: February 24, 2005 Reccived: March 16, 2005
Dear Dr. McDougall:
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 mendments, 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 such additional controls. Existing major regulations affecting (1 Mr.), it hay be doged 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.
4
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that I Dri 3 issualled or our device complies with other requirements of the Act that I DA has made a decemmations administered by other Federal agencies. You must of any I cactar stututes and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI'N Fatt 607), adoning (21 OFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation conta of pro neeting your device as described in your Section 510(k) This letter will anow you to ogin mailing of substantial equivalence of your device to a legally premarket notication: The PDF Intelling sification 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), please If you desire specific arrive ior Jose (240) 276-0115. Also, please note the regulation entitled, Contact the Office of Coursemarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miorinational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sulfite. Michael O. md.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Sgarlato Laboratories, Inc.
510(k) PainFree Pump - Additional Indication for Use, Section D, Page 4.1
Indications for Use
K043204 510(k) Number (if known):
Sgarlato PainFree Pump; Sgarlato Pain Control Infusion Pump Device Name:
Indications For Use:
The Sgarlato PainFree Pump is a single use, general purpose infusion device intended to provide continuous infusion of medication (such as local anesthetics or corticosteroids) directly into a target site for the purpose of pain relief. Infusion may be carried out via percutaneous, subcutaneous, and epidural routes. The PainFree Pump may be used to provide continuous infusion of a local anesthetic directly into an intraoperative site for postoperative management of pain following surgery. It is suitable for use as an ambulatory device. It is not intended for vascular drug delivery, hyperalimentation, or the delivery of blood or blood products.
Prescription Use Yes (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
i.e. 10 m
ision Sign-Off) Chision of Anesthesiology, General Hospital, in setion Control, Dental Devices
1 (k) Number _ N 443244
Page 1 of 1