(137 days)
The UPDATED SLIP Urology Introducer Sheath is intended to facilitate the introduction of catheters or instruments into the urethra. The UPDATED SLIP Urology Introducer Sheath is indicated for use as a guide for urological catheters or instruments inserted into the urethra and as a lubricious barrier between the urethral tissue and the catheter or instrument.
The UPDATED SLIP Urology Introducer Sheath consists of a membrane sheath, outer tube, stabilizing ring, and an obturator. The outer tube is pre-loaded with the membrane sheath.
The provided text describes a 510(k) premarket notification for a medical device, the "UPDATED SLIP Urology Introducer Sheath." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting a detailed clinical study with acceptance criteria, sample sizes, and expert evaluations as typically seen for novel or higher-risk devices.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable to this specific submission.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as performance metrics with numerical targets. The primary "acceptance criterion" for a 510(k) is demonstrating "substantial equivalence" to a predicate device.
- Reported Device Performance: The document states: "Performance data demonstrated no significant difference in the performance of the UPDATED SLIP Urology Sheath and the predicate device." This is a qualitative statement, not a numerical performance value against a defined criterion.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | No significant difference in performance compared to the predicate device (PSI SLIP Urology Introducer Sheath). |
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: Not specified. The document refers to "Performance data" but does not detail the nature, size, or methodology of any testing that generated this data.
- Data Provenance: Not specified.
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)
- Not Applicable. This type of expert assessment to establish ground truth for a test set is not typically part of a 510(k) submission for a device like an introducer sheath, which is focused on physical and functional equivalence rather than diagnostic accuracy or specific clinical outcomes requiring expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As no specific "test set" and expert ground truth establishment are described, there is no 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
- Not Applicable. An MRMC study is relevant for diagnostic devices, particularly those involving image interpretation or AI assistance. This device is an introducer sheath, a different class of medical device, and does not involve AI or human readers in the way an MRMC study would assess.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is not an algorithm or AI system. It is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. For this type of device and submission, the "ground truth" equivalent would be the established performance and safety profile of the predicate device, against which the new device is compared in terms of its technological characteristics and the absence of new safety/effectiveness questions.
8. The sample size for the training set
- Not Applicable. Training sets are relevant for AI/machine learning models. This device is not an AI/ML product.
9. How the ground truth for the training set was established
- Not Applicable. (See point 8).
Summary of what is known from the document regarding "performance data":
The document explicitly states: "Performance data demonstrated no significant difference in the performance of the UPDATED SLIP Urology Sheath and the predicate device." This indicates that some form of comparative evaluation was conducted to support the claim of substantial equivalence. However, the details of what kind of performance data (e.g., mechanical strength, lubricity, insertion force, biocompatibility), how it was collected, the sample size, or the specific methodology are not provided in this summary. For a 510(k), this level of detail is typically found in the full submission, not necessarily in the brief summary provided. The focus of the 510(k) is on the device's technical characteristics and intended use being similar to a legally marketed predicate device, ensuring no new questions of safety or effectiveness are raised.
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K042531
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FEB - 1 2005
510(k) SUMMARY
Percutaneous Systems, Inc.'s UPDATED SLIP Urology Introducer Sheath
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Percutaneous Systems, Inc. 1300 Crittenden Lane, #301 Mountain View, CA 94043-1359
(650) 969-8800 x 204 Phone: Facsimile: (650) 969-8801
Thomas Lawson Contact Person:
July 30, 2004 Date Prepared:
Common or Usual Name
Urology Introducer Sheath
Classification Name
Accessories, Catheter, G-U
Predicate Device
PSI SLIP Urology Introducer Sheath
Intended Use / Indications for Use
The UPDATED SLIP Urology Introducer Sheath is intended to facilitate the introduction of catheters or instruments into the urethra. The UPDATED SLIP Urology Introducer Sheath is indicated for use as a guide for urological catheters or instruments inserted into the urethra and as a lubricious barrier between the urethral tissue and the catheter or instrument.
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K042531
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Technological Characteristics
The UPDATED SLIP Urology Introducer Sheath consists of a membrane sheath, outer tube, stabilizing ring, and an obturator. The outer tube is pre-loaded with the membrane sheath.
Performance Data
Performance data demonstrated no significant difference in the r crosmance of the UPDATED SLIP Urology Sheath and the predicate device.
Substantial Equivalence
The UPDATED SLIP Urology Introducer Sheath has the same intended use, indications for use, and principles of operation and very similar technological characteristics as the predicate device. The minor technological differences between the UPDATED SLIP Urology Introducer Sheath and its predicate, namely, the UPDATED SLIP sheath's obturator, luminal seal, and stabilizing ring, do not raise any new questions of safety or effectiveness. Thus, the UPDATED SLIP II'm gay Introducer Sheath is substantially equivalent to the cleared SLIP Urology Introducer Sheath.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
FEB - 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Thomas Lawson, Ph.D. Director, Clinical Affairs Percutaneous Systems, Inc. 1300 Crittenden Lane, Suite 301 MOUNTAIN VIEW CA 94043
Re: K042531
Trade/Device Name: UPDATED SLIP Urology Introducer Sheath Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 KNY Dated: January 12, 2005 Received: January 13, 2005
Dear Dr. Lawson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreases) 70 ttg enactment date of the Medical Device Amendments, or to conninored processified 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 r ou may, ateres 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 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 i toals be active a a determination that your device complies with other requirements of the Act that I Dr Hab Intel and regulations administered by other Federal agencies. You must of any Featurers and 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 (21 Cr re rare out your ens (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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and by of substantial equivalence of your device of your device to a legally premaince notification - rivesults 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), please If you desire uponne at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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.gov/cdrb/dsmadsmamain.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K042531/
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Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: UPDATED SLIP Urology Introducer Sheath
Indications for Use:
The UPDATED SLIP Urology Introducer Sheath is intended to facilitate the introduction of catheters and instruments into the urethra.
The UPDATED SLIP Urology Introducer Sheath is indicated for use as a guide for urological catheters or instruments inserted into the a guide for aronogical consisted between the urethral tissue and the catheter or instrument.
Prescription Use x__________________________________________________________________________________________________________________________________________________________ Use (Per 21 C.F.R. 801.109)
AND/OR
Over-The-Counter
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of __
Nancy C Hodgson
(Division Sign-Off)
Division of Reproductive and Radiological Devices 510(k) Number
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.