(559 days)
The KSEA Neo-vagina Surgery Set and Accessories is indicated for use by qualified surgeons in women with congenital absence of the vagina who have failed first-line non-surgical treatment with conventional vaginal dilators. The set is used in conjunction with a laparoscopic surgical procedure to create and enlarge the vaginal cavity via continuous traction between the abdomen and vulva, and to maintain the vaginal canal after surgery.
The KSEA Neo-vagina Surgery Set and Accessories is indicated for use by qualified surgeons to be placed in the vagina to enlarge the vaginal cavity and maintain the vaginal canal after laparoscopic-assisted creation of a neo-vagina.
This is a 510(k) premarket notification for a medical device, which is an application seeking substantial equivalence to a legally marketed predicate device. This type of submission generally does not include detailed studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies as would be found in a De Novo or PMA submission. The focus of a 510(k) is to demonstrate that the new device is as safe and effective as (substantially equivalent to) an existing device.
Therefore, many of the requested details about acceptance criteria and specific study designs are typically not found within a 510(k) summary. I will extract the information that is present and note where the requested information is not available due to the nature of a 510(k) submission.
Here's the breakdown of the information provided in the document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: A 510(k) does not typically define explicit acceptance criteria in the same way a clinical trial or performance study for a novel device would. Instead, the "acceptance criteria" for a 510(k) is demonstrating
substantial equivalenceto a predicate device. This is achieved by showing that the new device has "similar basic features, design, and intended uses" and that "minor differences...raise no new issues of safety and effectiveness." - Reported Device Performance: The document states: "The KSEA Neo-vagina Surgery Set and Accessories is substantially equivalent to the predicate device since the basic features, design, and intended uses are similar. The minor differences between the KSEA Neo-vagina Surgery Set and Accessories and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function, or intended use of the devices."
Table of (Implied) Acceptance Criteria and Performance:
| Feature/Criterion | Acceptance Standard (Implied for 510(k)) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Device is as safe and effective as a legally marketed predicate device. Minor differences do not raise new issues of safety and effectiveness. | "The KSEA Neo-vagina Surgery Set and Accessories is substantially equivalent to the predicate device since the basic features, design, and intended uses are similar. The minor differences between the KSEA Neo-vagina Surgery Set and Accessories and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function, or intended use of the devices." |
| Basic Features & Design | Similar to predicate devices. | "Similar" |
| Intended Uses | Similar to predicate devices. | "The KSEA Neo-vagina Surgery Set and Accessories is indicated for use by qualified surgeons in women with congenital absence of the vagina who have failed first-line non-surgical treatment with conventional vaginal dilators. The set is used in conjunction with a laparoscopic surgical procedure to create and enlarge the vaginal cavity via continuous traction between the abdomen and vulva, and to maintain the vaginal canal after surgery." (Matches the predicate's intended use implicitly) |
| Technological Characteristics | Similar to predicate devices, ensuring biocompatibility, reusability, autoclavability, and range of sizes. | "The KSEA Neo-vagina Surgery Set and Accessories and its predicate devices are removable reusable devices, intended to enlarge the vagina by stretching and maintain vaginal patency. They are composed of biocompatible and autoclavable materials and are available in a range of sizes to meet the clinical and aesthetic needs of each case." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided in a 510(k) summary. A 510(k) application focuses on demonstrating equivalence to existing devices, often through comparative analysis of device specifications, materials, and intended use, rather than a clinical trial with a "test set" in the context of an AI/algorithm.
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)
- This information is not applicable/not provided. Ground truth establishment by experts is typically part of studies for novel devices or AI algorithms. This 510(k) is for a surgical instrument set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable/not provided. Adjudication methods are relevant for studies where expert consensus on interpretations (e.g., from images) is needed.
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 information is not applicable/not provided. MRMC studies are specific to evaluating diagnostic devices, especially those incorporating AI, and are not part of a 510(k) for a surgical instrument set. The device described is a set of physical surgical instruments, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable/not provided. There is no algorithm or AI component in this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- This information is not applicable/not provided. As this is a surgical instrument set and not a diagnostic or AI device, the concept of "ground truth" for performance evaluation in a structured study is not directly relevant in the 510(k) summary provided.
8. The sample size for the training set
- This information is not applicable/not provided. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- This information is not applicable/not provided. There is no "training set" or "ground truth" in the context of an AI/ML device for this submission.
Summary of the Study (Implied by 510(k) Process):
The "study" in a 510(k) context is a comparative analysis of the new device against a legally marketed predicate device(s).
- Design: The submission performs a comparison of the KSEA Neo-vagina Surgery Set and Accessories against two predicate devices: Bioteque America, Inc. (K003380) and Specialities REMEEX International, S.L. (K033310).
- Objective: To demonstrate that the new device is "substantially equivalent" to these predicates in terms of basic features, design, intended use, and technological characteristics, and that any differences do not raise new issues of safety and effectiveness.
- Methodology: The summary states that the devices are compared based on their design, intended uses, and technological characteristics (removable, reusable, biocompatible, autoclavable materials, range of sizes).
- Outcome: The conclusion is that the KSEA Neo-vagina Surgery Set and Accessories is substantially equivalent to the predicate devices.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the date "JAN - 7 2009" on the left side. To the right of the date is the logo for STORZ, with the words "KARL STORZ ENDOSCOPY" written underneath. The logo is in black and white and has a bold, sans-serif font. The image appears to be a scan or photocopy of a document.
| 510(K) SUMMARY | |
|---|---|
| Sponsor/Submitter: | Karl Storz Endoscopy-America, Inc. |
| Contact Person: | Crystal DizolRegulatory Affairs SpecialistEmail: cdizol@ksea.com |
| Date of Submission: | June 26, 2007 |
| Device Trade Name: | Karl Storz Neo-vagina Surgery Set and Accessories |
| Common Name: | Vaginal Dilator |
| Classification Name: | Vaginal Stent |
| Regulation Number: | 21 CFR § 4.3900 |
| Product Code: | HDX |
| Predicate Device(s): | Bioteque America, Inc. (K003380)Specialities REMEEX International, S.L. (K033310) |
| Device Description: | The KSEA Neo-vagina Surgery Set and Accessories is indicated for use byqualified surgeons to be placed in the vagina to enlarge the vaginal cavity andmaintain the vaginal canal after laparoscopic-assisted creation of a neo-vagina. |
| Indications for Use: | The KSEA Neo-vagina Surgery Set and Accessories is indicated for use byqualified surgeons in women with congenital absence of the vagina who havefailed first-line non-surgical treatment with conventional vaginal dilators. The setis used in conjunction with a laparoscopic surgical procedure to create andenlarge the vaginal cavity via continuous traction between the abdomen andvulva, and to maintain the vaginal canal after surgery. |
| TechnologicalCharacteristics: | The KSEA Neo-vagina Surgery Set and Accessories and its predicate devicesare removable reusable devices, intended to enlarge the vagina by stretchingand maintain vaginal patency. They are composed of biocompatible andautoclavable materials and are available in a range of sizes to meet the clinicaland aesthetic needs of each case. |
| Summary ofSubstantialEquivalence: | The KSEA Neo-vagina Surgery Set and Accessories is substantially equivalentto the predicate device since the basic features, design, and intended uses aresimilar. The minor differences between the KSEA Neo-vagina Surgery Set andAccessories and the predicate devices raise no new issues of safety andeffectiveness, as these design differences have no effect on the performance,function, or intended use of the devices. |
.
r
् :
.
:
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three horizontal bars representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is in all capital letters.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 7 2009
Ms. Crystal Dizol. Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe CULVER CITY CA 90230-7600
Re: K071754
Trade/Device Name: KSEA Neo-vagina Surgery Set and Accessories Regulation Number: 21 CFR §884.3900 Regulation Name: Vaginal stent Regulatory Class: II Product Code: HDX Dated: December 29, 2008 Received: December 30, 2008
Dear Ms. Dizol:
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 indictions 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 The general controls provisions of the Act include requirements for annual registration, including 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.
{2}------------------------------------------------
Page 2
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jozue M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
INDICATIONS FOR USE
K071754 510(k) Number:
Device Name: KSEA Neo-vagina Surgery Set and Accessories
- Indications for Use: The KSEA Neo-vagina Surgery Set and Accessories is indicated for use by qualified surgeons in women with congenital absence of the vagina who have failed first-line non-surgical treatment with conventional vaginal dilators. The set is used in conjunction with a laparoscopic surgical procedure to create and enlarge the vaginal cavity via continuous traction between the abdomen and vulva, and to maintain the vaginal canal after surgery.
Prescription Use:
(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)
Halus Remen
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 884.3900 Vaginal stent.
(a)
Identification. A vaginal stent is a device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery.(b)
Classification. Class II (performance standards).