(132 days)
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.
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. 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 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.
This looks like a 510(k) summary for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details about a clinical study with detailed acceptance criteria and performance data in the way a PMA or clinical trial summary would.
Therefore, many of the requested items (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of submission.
The document describes the acceptance criteria by comparing the new device (Sgarlato PainFree pump) to two predicate devices (Paragon Infusion Kit K984146 and Sgarlato Pain Control Infusion Pump K990101) to establish substantial equivalence. The "performance" is demonstrated through this comparison, showing that its specifications are similar to or within the expected range of already cleared devices for its expanded indications.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The device demonstrates "performance" by being substantially equivalent to the predicate devices. The acceptance criteria are essentially met if the characteristics of the Sgarlato PainFree Pump are comparable to the Paragon Infusion Kit and the Sgarlato PCIP (Sgarlato Pain Control Infusion Pump), especially regarding the new indications.
| Item | Acceptance Criteria (from Predicate Devices) | Sgarlato PainFree Pump Performance (from device description) |
|---|---|---|
| Intended Use | Variety of continuous infusion for pain management (Intraoperative for PCIP; General Infusion for Paragon) | Continuous infusion of medication into a target site for pain management |
| Routes of Administration | Percutaneous (PCIP); Percutaneous, subcutaneous, intramuscular, and epidural (Paragon) | Percutaneous, subcutaneous, and epidural |
| Contraindications | Not for IV, blood products, lipids (Paragon); Not for epidural, subcutaneous, vascular, blood products, TPN (PCIP) | Not for IV, blood products, lipids, or fat emulsions |
| Reuse | Reusable pump, single-use administration sets (Paragon); Single Use (PCIP) | Single Use |
| Fill Volumes | 100 ml (Paragon); 100 or 200 ml (PCIP) | 100 or 200 ml |
| Flow Rates | 0.5, 1, 2, 4, or 10 ml/hr (Paragon); 0.5, 1, or 2 ml/hr (PCIP) | 1, 2, or 4 ml/hr |
| Flow control | Micro-bore tubing with medication filter (both predicates) | Micro-bore tubing with 5 micron medication filter |
| Pump Mechanism | Spring-scissors plate compressing PVC bag (Paragon); Spring-powered syringe plunger (PCIP) | Spring-powered syringe plunger |
| Power | Compressed spring (both predicates) | Compressed spring |
| Components and Materials | Conform with ISO 10993 part 1 for fluid path (both predicates) | Conform with ISO 10993 part 1 for fluid path |
| Safety/Alarms | None except fluid level indicator/plunger movement monitors flow (both predicates) | None except plunger movement monitors flow |
| Packaging | Tyvek-sealed tray with pump, administration sets, accessories (both predicates) | Tyvek-sealed tray with pump, administration sets, accessories, and catheter sets |
2. Sample size used for the test set and the data provenance
Not applicable/Not provided within this 510(k) summary. This document relies on comparison to predicate devices, not a separate "test set" with patient data. The "test" is the comparison of device specifications and intended use against existing cleared devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. This is not a study requiring expert ground truth in the traditional sense. The "ground truth" for substantial equivalence is the FDA's existing clearances for the predicate devices.
4. Adjudication method for the test set
Not applicable/Not provided. No "test set" or adjudication process described as part of this substantial equivalence determination.
5. 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 an infusion pump, not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is an infusion pump, not an algorithm. Its operation is purely mechanical.
7. The type of ground truth used
The "ground truth" for this 510(k) submission is the FDA's prior clearance of the predicate devices based on their established safety and effectiveness. The Sgarlato PainFree pump is deemed substantially equivalent if it shares similar technological characteristics and has the same or similar intended use, without raising new questions of safety and effectiveness, as demonstrated by the comparison table and descriptive text.
8. The sample size for the training set
Not applicable/Not provided. This is a mechanical medical device, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable/Not provided. As above, no training set is relevant for this type of device submission.
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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.
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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.
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| Paragon Infusion Kit(K984146) | Sgarlato PCIP(K896422) | Sgarlato PainFreePump (review item) | |
|---|---|---|---|
| Item | |||
| Intended Use | Continuous infusion ofmedication into anintraoperative site forgeneral surgery andpain management.The pump itself is forgeneral infusion use. | Continuous infusion oflocal anesthetic into asurgical site forpostoperative painmanagement | Continuous infusion ofmedication into atarget site for painmanagement |
| Routes ofAdministration | Percutaneous,subcutaneous,intramuscular, andepidural | Percutaneous | Percutaneous,subcutaneous, andepidural |
| Contraindications | Not for intravenousdelivery. Not intendedfor blood, bloodproducts, lipids, or fatemulsions | Not for epidural,subcutaneous, orvascular drugdelivery. Not fordelivery of blood,blood products, orTPN | Not for intravenousdelivery. Not intendedfor blood, bloodproducts, lipids, or fatemulsions |
| Reuse | Re-usable pump,single useadministration 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 withmedication filter | Micro-bore tubing with5 micron medicationfilter | Micro-bore tubing with5 micron medicationfilter |
| Pump Mechanism | Spring-scissors platecompressing PVC bag | Spring-poweredsyringe plunger | Spring-poweredsyringe plunger |
| Power | Compressed spring | Compressed spring | Compressed spring |
| Components andMaterials | Conform with ISO10993 part 1 for fluidpath | Conform with ISO10993 part 1 for fluidpath | Conform with ISO10993 part 1 for fluidpath |
| Safety/Alarms | None except Fluidlevel indicator tomonitor flow | None except plungermovement monitorsflow | None except plungermovement monitorsflow |
| Packaging | Tyvek-sealed traycontaining pump,administration sets,and accessories.Flow restrictors, andy- connector sets,may be separatelypackaged | Tyvek-sealed traycontaining pump,administration sets,and accessories.Flow restrictors, and yconnector sets, maybe separatelypackaged | Tyvek-sealed traycontaining pump,administration sets,and accessories.Flow restrictors, y-connector sets, andcatheter sets may beseparately packaged |
Comparison to legally marketed Devices
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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.
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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
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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
§ 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).