(83 days)
The High Dose Disconnect Cap and MiniCap with Povidone-Iodine Solution (5C4486) are single use caps that are intended for use with appropriate Peritoneal Dialysis (PD) products. The High Dose Cap is designed to isolate (cap off) the Easy-Lock™ connector (patient line) of the PD disposable set. The MiniCap is designed to isolate (cap off) the Easy-LockTM connector of the patient's transfer set.
The High Dose Disconnect Cap with Povidone-Iodine Solution (5C4456) is a single use cap that is intended for use with appropriate Peritoneal Dialysis (PD) disposable products. The High Dose Cap is designed to isolate (cap off) the Easy-Lock™ connector (patient line) of the PD disposable set.
The High Dose Disconnect Cap and MiniCap with Povidone-Iodine Solution (5C4486) consists of the High Dose Disconnect Cap, which contains a povidone iodine impregnated polyurethane sponge, a spacer, and a MiniCap. The MiniCap also contains a povidone iodine impregnated polyurethane sponge. The povidone iodine sponge is used to disinfect the mating interface between the disconnect caps (High Dose Cap and MiniCap) and the patient connector of the PD disposable set and the patient transfer set, respectively. The High Dose Cap and the MiniCap are packaged together to conveniently allow the patient to disconnect from the peritoneal cycler therapy when desired. The spacer aids in the convenience packaging of the two caps into one product and has no other functional use. The MiniCap product is currently cleared for marketing under K895631 and is sold separately.
Similarly, the High Dose Disconnect Cap with Povidone-Iodine Solution (5C4456) simply consists of the High Dose Disconnect Cap and a povidone iodine impregnated polyurethane sponge. The povidone iodine sponge is used to disinfect the mating interface between the disconnect cap and the patient connector of the PD disposable set.
In general, the design and materials of the subject disposable disconnect caps are similar to the Baxter predicate devices. The caps provide an integral seal to the mating part, have exterior ribs to facilitate use, and contain a iodine impregnated sponge for disinfecting purposes.
The provided text describes a 510(k) summary for the "High Dose Disconnect Cap and MiniCap with Povidone-Iodine Solution (5C4486) and High Dose Disconnect Cap with Povidone-Iodine Solution (5C4456)".
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Microbiological | "The High Dose Disconnect Cap was able to deliver the desired kill of the test organism." |
| Cap/Connector Seal | "Additionally, the cap/connector seal passed the specified pressure test." |
| Ease of Use (Torque) | "The torque to remove the cap is not greater than currently available disconnect caps." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document does not specify the sample size used for any of the tests (microbiological, cap/connector seal, or ease of use).
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It is a 510(k) submission from Baxter Healthcare Corporation, based in McGaw Park, IL, suggesting the tests were likely conducted in the US.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- The document describes performance/functional testing (microbiological, seal, torque). For these types of tests, "ground truth" as typically understood in AI/medical imaging contexts (e.g., expert consensus on image interpretation) is not directly applicable. The "ground truth" for these tests would be established by the defined test methods (e.g., a specific microbial reduction level, a specific pressure retention).
- Therefore, the document does not mention a number of experts or their qualifications for establishing ground truth for these specific performance tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- As mentioned above, the tests are performance/functional in nature, not involving interpretation by multiple human readers that would require an adjudication method.
- Therefore, the document does not describe an adjudication method.
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:
- This device is a physical medical device (disconnect caps with povidone-iodine solution), not an AI-powered diagnostic or assistive technology.
- Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is a physical device, not an algorithm.
- Therefore, a standalone algorithm performance study is not applicable and was not done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the microbiological test, the "ground truth" would be the measurable "desired kill of the test organism" as defined by a standard microbiological test method.
- For the cap/connector seal test, the "ground truth" is the "specified pressure test" passed.
- For the ease of use (torque) test, the "ground truth" is the comparison against "currently available disconnect caps."
8. The sample size for the training set:
- This device is a physical medical device; it does not involve a training set in the context of machine learning or AI.
9. How the ground truth for the training set was established:
- Since there is no training set for this physical device, this question is not applicable.
{0}------------------------------------------------
Page 1/2
510(k) SUMMARY
. D
్లు
| Submitter's name andAddress: | David C. Ross, Pharm.D., MBA, RACAssociate Director, Regulatory AffairsBaxter Healthcare Corporation, Renal Division1620 Waukegan RoadMcGaw Park, IL 60085 | OCT - 1 1997 |
|---|---|---|
| Telephone Number:Fax Number: | (847) 473-6081(847) 473-6952 | |
| Contact: | David Ross | |
| Trade Name: | High Dose Disconnect Cap and MiniCap with Povidone-Iodine Solution (5C4486) and High Dose Disconnect Capwith Povidone-Iodine Solution (5C4456) | |
| Common Name: | Disconnect caps for Peritoneal Dialysis (PD) therapy | |
| Classification Name: | Peritoneal dialysis system and accessories per 21 CFR876.5630 | |
| Equivalent Predicate: | Baxter's Easy Lock™ Disconnect Cap with Povidone-IodineSolution ( K895631), Baxter's disconnect MiniCap withPovidone-Iodine Solution ( K895631), and the Medionics QCCap (K945567) | |
| Device Description: | The High Dose Disconnect Cap and MiniCap with Povidone-Iodine Solution (5C4486) consists of the High DoseDisconnect Cap, which contains a povidone iodineimpregnated polyurethane sponge, a spacer, and a MiniCap.The MiniCap also contains a povidone iodine impregnatedpolyurethane sponge. The povidone iodine sponge is used todisinfect the mating interface between the disconnect caps(High Dose Cap and MiniCap) and the patient connector ofthe PD disposable set and the patient transfer set,respectively. The High Dose Cap and the MiniCap arepackaged together to conveniently allow the patient todisconnect from the peritoneal cycler therapy when desired.The spacer aids in the convenience packaging of the two capsinto one product and has no other functional use. TheMiniCap product is currently cleared for marketing underK895631 and is sold separately. |
41
:
{1}------------------------------------------------
K972579
Similarly, the High Dose Disconnect Cap with Povidone-Iodine Solution (5C4456) simply consists of the High Dose Disconnect Cap and a povidone iodine impregnated polyurethane sponge. The povidone iodine sponge is used to disinfect the mating interface between the disconnect cap and the patient connector of the PD disposable set.
The High Dose Disconnect Cap and MiniCap with Povidone-Intended Use: Iodine Solution (5C4486) are single use caps that are intended for use with appropriate Peritoneal Dialysis (PD) products. The High Dose Disconnect Cap is designed to isolate (cap off) the Easy-Lock™ connector (patient line) of the PD disposable set. The MiniCap is designed to isolate (cap off) the Easy-LockTM connector of the patient's transfer set.
The High Dose Disconnect Cap with Povidone-Iodine Solution (5C4456) is a single use cap that is intended for use with appropriate Peritoneal Dialysis (PD) disposable products. The High Dose Cap is designed to isolate (cap off) the Easy-Lock™ connector (patient line) of the PD disposable set.
In general, the design and materials of the subject disposable disconnect caps are similar to the Baxter predicate devices. The caps provide an integral seal to the mating part, have exterior ribs to facilitate use, and contain a iodine impregnated sponge for disinfecting purposes.
Not applicable
None to date.
The performance/functional testing included microbiological, cap/connecter seal, and ease of use (torque) testing. The data demonstrate that the High Dose Disconnect Cap was able to deliver the desired kill of the test organism. Additionally, the cap/connector seal passed the specified pressure test and the torque to remove the cap is not greater than currently available disconnect caps.
Additional information requested by FDA:
Summary of the technological
Clinical Data:
tests:
characteristics compared
Conclusions drawn from
to the predicate device:
David C. Ross
David C. Ross, Pharm.D., MBA, RAC Associate Director, Regulatory Affairs
July 8, 1997
Date
2|2
{2}------------------------------------------------
Image /page/2/Picture/2 description: The image shows a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract symbol to the right, consisting of three curved lines that resemble human figures. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert L. Wilkinson, RAC Director, Regulatory Affairs Baxter Healthcare Corporation 1620 Waukegan Road McGaw Park, Illinois 60085-6730 1997
Re: K972579
High Dose Disconnect Cap and MiniCap with Povidone-Iodine Solution (5C4486) and High Dose Disconnect Cap with Povidone-Iodine Solution (5C4456) Dated: July 8, 1997 Received: July 10, 1997 Regulatory class: II 21 CFR §876.5630/Product code: 78 KDJ
Dear Mr. Wilkinson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate.commence. 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
William Yin
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
{3}------------------------------------------------
510(k) Premarket Notification
High Dose Disconnect Cap and MiniCap with Povidone-Iodine Solution (5C4486) and High Dose Disconnect Cap with Povidone-Iodine Solution (5C4456)
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
2 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1
Device Name: High Dose Disconnect Cap and MiniCap with Povidone-Iodine Solution (5C4486) and High Dose Disconnect Cap with Povidone-Iodine Solution (5C4456)
Indication for Use: The High Dose Disconnect Cap and MiniCap with Povidone-Iodine Solution (5C4486) are single use caps that are intended for use with appropriate Peritoneal Dialysis (PD) products. The High Dose Cap is designed to isolate (cap off) the Easy-Lock™ connector (patient line) of the PD disposable set. The MiniCap is designed to isolate (cap off) the Easy-Lock™ connector of the patient's transfer set.
The High Dose Disconnect Cap with Povidone-Iodine Solution (5C4456) is a single use cap that is intended for use with appropriate Peritoneal Dialysis (PD) disposable products. The High Dose Cap is designed to isolate (cap off) the Easy-Lock™ connector (patient line) of the PD disposable set.
· (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Robert D. Sather | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, | |
| and Radiological Devices | |
| 510(k) Number | K972579 |
| Prescription Use | OR | Over-The-Counter Use ______ |
|---|---|---|
| (Per 21 CFR 801.109) |
0 ਰੇ
§ 876.5630 Peritoneal dialysis system and accessories.
(a)
Identification. (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments.
(3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles.
(4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.
(b)
Classification. Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.