(16 days)
The DANA Diabecare® II external programmable syringe infusion pump and the SUPERLINE-EasyRelease, Soft-Release-ST, and Soft-Release-R Infusion Sets are indicated for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. The pump and administration sets are not intended for use with blood or blood products.
The DANA Diabecare® II insulin pump, SUPERLINE-EasyRelease (EasyRelease) Infusion Set, and Soft-Release Infusion Sets are modifications of the DANA Diabecare® insulin pump and SUPERLINE infusion set that were described in K001604, the 510(k) premarket notification for the DANA Diabecare® insulin infusion pump. The modifications made to the parent DANA Diabecare® insulin pump to produce the modified DANA Diabecare® II Insulin Pump were limited to software modifications including changes to the basal and bolus insulin delivery modes. features accessed via the password-protected (lock-out) mode, and the addition of alarms, a fail-safe function, and the ability to store and retrieve information (alarm, bolus dose, daily insulin dose). The overall design of the proposed EasyRelease, Soft-Release-ST, and Soft-Release-R Infusion Sets is identical to the design of the parent SUPERLINE Infusion Set. The design modifications are limited to the following: - Addition of a site for disconnecting the insulin pump from the infusion set . without removing the needle from the abdomen - Replacement of the infusion needle with an indwelling soft cannula (Soft-. Release-R and Soft-Release-ST only) The two versions of the Soft-Release Infusion Sets differ in the design of the detachment site and cannula assembly. The Soft-Release-R Infusion Set has a sliding lock detachment site and a "rectangular" cannula oriented perpendicular to the infusion tubing axis. The Soft-Release-ST has a turning screw lock detachment site that uses a conical fitting and a straight cannula oriented parallel to the infusion tubing axis. There are minor differences in the materials used for the construction of the proposed EasyRelease, Soft-Release-ST, and Soft-Release-R Infusion Sets as compared to the parent SUPERLINE.
Here's an analysis of the provided text regarding the DANA Diabecare® II Insulin Pump and SUPERLINE Infusion Sets, focusing on acceptance criteria and supporting studies:
It's important to note that the provided text is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full, detailed study report with extensive acceptance criteria and performance statistics like a PMA. Therefore, some of the requested information (especially quantitative data, training set details, or complex study designs like MRMC) is not explicitly present or as detailed as one might expect in a scientific publication.
Acceptance Criteria and Reported Device Performance
The document describes several performance tests and their outcomes, which serve as the acceptance criteria for ensuring the modifications made to the device still meet safety and effectiveness standards.
| Acceptance Criteria / Performance Test | Reported Device Performance |
|---|---|
| Biocompatibility | Sooil has conducted the necessary testing to satisfy the biocompatibility requirements of ISO 10993-1 for use as an insulin administration set. (Implies compliance with ISO 10993-1 standards) |
| Burst Testing | Confirms that the detachment sites incorporated in the EasyRelease and Soft-Release Infusion Sets do not leak. (Implies meeting a no-leakage standard) |
| Bioburden Testing | Confirms that the fluid path remains sterile following repeated detachment/reattachment procedures. (Implies meeting sterility standards, likely below a certain bioburden limit for medical devices) |
| Unexpected Detachment | Confirms that the detachment sites incorporated in the EasyRelease and Soft-Release Infusion Sets do not unexpectedly detach. (Implies meeting a standard for secure attachment/detachment) |
| Insulin Potency Assay (Stability) | Indicates that insulin remains stable for up to 120 hours in the EasyRelease and Soft-Release Infusion Sets. (Implies no significant degradation or loss of potency of insulin over this period, meeting a pre-defined stability threshold) |
| Shelf-Life Testing | Supported a three-year shelf life for the EasyRelease and Soft-Release Infusion Sets. (Implies meeting stability, sterility, and functional requirements over a three-year period) |
| Software Modifications | Changes to basal/bolus delivery, password-protected modes, addition of alarms, fail-safe function, and data storage/retrieval. (Implies successful implementation and intended functionality of these changes; specific acceptance criteria for each software feature are not detailed but would typically involve functional testing). |
Additional Information on the Study (if available)
-
Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample sizes for the burst, bioburden, insulin potency, or shelf-life testing. These would typically be determined by statistical methods or regulatory guidance for such tests.
- The data provenance (e.g., country of origin, retrospective/prospective) is not specified. Given the manufacturer is from Korea, it's likely the testing was performed there or by a contract lab; however, this is not confirmed in the text. This is a design verification activity, not a clinical trial.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to the described performance testing. The "ground truth" for burst, bioburden, and insulin stability tests is typically established through objective measurements against defined chemical, physical, and microbiological standards, not relying on expert interpretation in the same way as, for example, image interpretation in a diagnostic device.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes, where there might be disagreement. These are objective engineering and laboratory tests.
-
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:
- This is not applicable as this device is an insulin pump and infusion set, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was mentioned or would be relevant.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is a medical device (pump and infusion sets), not a standalone algorithm or AI. While the pump has software with algorithms, the "standalone" performance here relates to the device's functional integrity (e.g., accurate insulin delivery, absence of leaks), not an AI's interpretative power.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the described tests:
- Biocompatibility: Ground truth is established by adherence to ISO 10993-1 standards and validated laboratory test results (e.g., cytotoxicity assays, sensitization tests).
- Burst Testing: Ground truth is the physical presence or absence of leakage under specified pressure.
- Bioburden Testing: Ground truth is the microbiological count meeting sterility assurance levels.
- Insulin Potency Assay: Ground truth is the measured concentration/activity of insulin remaining relative to a control or baseline, determined by validated chemical assays.
- Shelf-Life Testing: Ground truth is the maintenance of all specified performance criteria (e.g., sterility, dimensional stability, material integrity, functional operation) over the stated period.
- These are all objective, laboratory-based measurements against established scientific and regulatory standards.
- For the described tests:
-
The sample size for the training set:
- Not applicable. This is not a machine learning model, so there is no "training set." The development of the device involves engineering design, material selection, and verification testing.
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
In summary: The provided 510(k) summary focuses on demonstrating the safety and effectiveness of the physical device modifications through performance testing against established engineering and regulatory standards (e.g., biocompatibility, physical integrity, stability). It does not involve AI or diagnostic interpretations, thus many of the questions related to AI/algorithmic performance, human readers, and ground truth in that context are not relevant to this submission.
{0}------------------------------------------------
AUG 0 2 2002 510(k) Summary
for
DANA Diabecare® II Insulin Pump and SUPERLINE-EasyRelease, Soft-Release-ST, and Soft-Release-R Infusion Sets
SPONSOR 1.
Sooil Development Co., Ltd. 111-1, Heukseokl-Dong, Dongjak-Ku Seoul, 156-071 KOREA
| Contact Person: | Soo Bong Choi |
|---|---|
| Telephone: | 82-441-845-2129 (Telephone) |
| 82-441-845-2128 (Facsimile) |
July 16, 2002 Date Prepared:
2. DEVICE NAME
| Proprietary Name: | DANA Diabecare® II Insulin Pump and SUPERLINE-EasyRelease, Soft-Release-ST, and Soft-Release-RInfusion Sets |
|---|---|
| Common/Usual Name: | Insulin infusion pump and infusion set accessories |
| Classification Name: | Infusion pump |
3. PREDICATE DEVICES
DANA Diabecare® insulin pump and SUPERLINE infusion set (Sooil Development Co., Ltd., K001604)
DEVICE DESCRIPTION 4.
The DANA Diabecare® II insulin pump, SUPERLINE-EasyRelease (EasyRelease) Infusion Set, and Soft-Release Infusion Sets are modifications of the DANA Diabecare® insulin pump and SUPERLINE infusion set that were described in K001604, the 510(k) premarket notification for the DANA Diabecare® insulin infusion pump.
{1}------------------------------------------------
ડ. INTENDED USE
The DANA Diabecare® II external programmable syringe infusion pump and the SUPERLINE-EasyRelease, Soft-Release-R, and Soft-Release-ST Infusion Sets are indicated for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. The pump and administration sets are not intended for use with blood or blood products.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The modifications made to the parent DANA Diabecare® insulin pump and SUPERLINE Infusion Set to produce the proposed DANA Diabecare® II Insulin Pump and the EasyRelease, Soft-Release-ST, and Soft-Release-R Infusion Sets were implemented to enhance the convenience, ease of use, and comfort of the devices.
The modifications made to the parent DANA Diabecare® insulin pump to produce the modified DANA Diabecare® II Insulin Pump were limited to software modifications including changes to the basal and bolus insulin delivery modes. features accessed via the password-protected (lock-out) mode, and the addition of alarms, a fail-safe function, and the ability to store and retrieve information (alarm, bolus dose, daily insulin dose).
The overall design of the proposed EasyRelease, Soft-Release-ST, and Soft-Release-R Infusion Sets is identical to the design of the parent SUPERLINE Infusion Set. The design modifications are limited to the following:
- Addition of a site for disconnecting the insulin pump from the infusion set . without removing the needle from the abdomen
- Replacement of the infusion needle with an indwelling soft cannula (Soft-. Release-R and Soft-Release-ST only)
The two versions of the Soft-Release Infusion Sets differ in the design of the detachment site and cannula assembly. The Soft-Release-R Infusion Set has a sliding lock detachment site and a "rectangular" cannula oriented perpendicular to the infusion tubing axis. The Soft-Release-ST has a turning screw lock detachment site that uses a conical fitting and a straight cannula oriented parallel to the infusion tubing axis.
There are minor differences in the materials used for the construction of the proposed EasyRelease, Soft-Release-ST, and Soft-Release-R Infusion Sets as compared to the parent SUPERLINE. Sooil has conducted the necessary testing to satisfy the
{2}------------------------------------------------
biocompatibility requirements of ISO 10993-1 for use as an insulin administration set.
7. PERFORMANCE TESTING
In addition to the biocompatibility testing mentioned in the previous section, design verification activities included burst testing, bioburden testing, insulin potency assay, and shelf-life testing. The results of the burst and bioburden tests confirm that the detachment sites incorporated in the EasyRelease and Soft-Release Infusion Sets do not leak or unexpectedly detach and the fluid path remains sterile following repeated detachment/reattachment procedures. The insulin potency assay indicates that insulin remains stable for up to 120 hours in the EasyRelease and Soft-Release Infusion Sets. The shelf-life testing supported a three-year shelf life for the EasyRelease and Soft-Release Infusion Sets.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the first profile being the largest and the third profile being the smallest.
Public Health Service
AUG 0 2 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sooil Development Company Limited Ms. Cynthia J. M. Nolte Consultant Medical Device Consultanting, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
Re: K022317
Trade/Device Name: DANA Diabecare® II Insulin Pump and SUPERLINE-Easy Release, Soft-Release-ST, and Soft-Release-R Infusion Sets Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: July 16, 2002 Received: July 17, 2002
Dear Ms. Nolte:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 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.
{4}------------------------------------------------
Page 2 – Ms. Nolte
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
the world of the starting of the starting of the starting of the starting of the first of the first of the first of the first of the first of the first of the first of the fi
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
{5}------------------------------------------------
K 02 2317 510(k) Number (if known):
Device Name: DANA Diabecare® II Insulin Pump and SUPERLINE-EasyRelease, Soft-Release-ST, and Soft-Release-R Infusion Sets
Indications for Use:
The DANA Diabecare® II external programmable syringe infusion pump and the SUPERLINE-EasyRelease, Soft-Release-ST, and Soft-Release-R Infusion Sets are used for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. These devices are not intended for use with blood or blood products.
(Please do not write below this line - Continue on another page if necessary)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricia Ciccerite
Division Sign-Off Division of Dental, Infection Control, and General Hospital Devi 510(k) Number _
V Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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).