(86 days)
The AMS Foreign Body Extractor is intended for use in the removal of a foreign body from the bladder under direct vision.
The AMS Foreign Body Extractor is made of stainless steel and consists of an obturator, sheath, grasper, seals, handle, security clip, telescope stabilizers and ACMI adaptor ring. The AMS Foreign Body Extractor Accessory Kit contains replacement security clip, telescope stabilizers, ACMI adaptor ring, and seals. To facilitate insertion into the urethra and bladder, the obturator is placed inside the sheath. Once inside the bladder, the obturator is removed and the grasper is placed within the lumen of the sheath. The handle is then attached and the telescope inserted into the sheath. The grasping jaws are operated by moving the handle to open and close the grasping jaws to capture and remove the foreign body.
The provided document, a 510(k) Premarket Notification for the AMS Foreign Body Extractor, describes the device and its intended use but does not contain detailed acceptance criteria or a comprehensive study demonstrating that the device meets specific performance criteria through clinical trials or extensive bench testing with quantifiable results.
The document states:
- "American Medical Systems has provided descriptive data on the test plan and test results for the Foreign Body Extractor. These data support that the function and characteristics of the device are suitable for its intended use."
- "All components are verified to ensure that only those meeting all parameters are released for sale."
However, it does not provide the specifics of these "descriptive data," "test plan," "test results," or the "parameters" used for verification. Therefore, I cannot construct a table of acceptance criteria and reported device performance, nor can I answer many of the subsequent questions based solely on the provided text.
Here's what can be inferred and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from intended use) | Reported Device Performance |
|---|---|
| Ability to grasp foreign bodies in the bladder | Not explicitly quantified in this document. |
| Ability to retract foreign bodies within a sheath | Not explicitly quantified in this document. |
| Ability to remove foreign bodies from the bladder | Not explicitly quantified in this document. |
| Operable under direct vision | Implied by "operated by moving the handle to open and close the grasping jaws to capture and remove the foreign body" and "under direct vision." No specific performance metrics for this. |
| Biocompatibility of materials (stainless steel) | "The material has previously undergone biocompatibility testing." No specifics on acceptance criteria or results. |
| Component verified to meet parameters | "All components are verified to ensure that only those meeting all parameters are released for sale." No specifics on parameters or verification results. |
Regarding the study that proves the device meets the acceptance criteria:
The document describes "Bench Testing" but provides no details on the study design, sample sizes, or specific results. It only states: "American Medical Systems has provided descriptive data on the test plan and test results for the Foreign Body Extractor. These data support that the function and characteristics of the device are suitable for its intended use."
Here's a breakdown of the other requested information based on the provided text, highlighting what is unavailable:
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified.
- Data provenance: Not specified. It's likely bench testing conducted by American Medical Systems, Inc. in Minnetonka, MN, USA. However, whether "descriptive data" implies internal prospective testing or retrospective analysis is not stated.
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/Not specified. The testing described appears to be bench testing, not involving expert interpretation or ground truth establishment in a clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified.
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 a surgical instrument, not an AI-based diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a manual surgical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified. For bench testing, "ground truth" would likely refer to engineering specifications and performance metrics (e.g., grasping force, retraction distance, material strength).
8. The sample size for the training set
- Not applicable. This is a direct-use medical device, not a machine learning algorithm requiring a "training set."
9. How the ground truth for the training set was established
- Not applicable.
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Image /page/0/Picture/0 description: The image shows the logo for Pfizer, a pharmaceutical company. The logo consists of the word "Pfizer" in a stylized font, with the "P" and "f" connected. The wordmark is set against a dark oval background. The logo is simple and recognizable, and it is often used in Pfizer's marketing and branding materials.
A country Madead over a Pfizer Hospital Products Group 10700 Bren Road West Minnetonka, MN 55343 Tel 612 933 4666 Fax 612 930 6592 Toll Free 800 328 3881
81 .42
Image /page/0/Picture/4 description: The image shows the logo for American Medical Systems, with the text "American Medical Systems" to the right of the logo. Below the text is the date "AUG 2 9 1997". The logo is a stylized "A" with horizontal lines.
SUMMARY OF SAFETY AND EFFECTIVENESS
SUBMITTER I.
Name and Address:
American Medical Systems, Inc. 10700 Bren Road West Minnetonka, MN 55343
Lisa L Pritchard Contact Person:
June 2, 1997 Date of Summary Preparation:
Establishment Registration Number: 2183959
II. DEVICE NAME
Device Common or Usual Name:
Device Trade Name:
AMS Foreign Body Extractor
Foreign Body Extractor
III. PREDICATE DEVICE
Gastroenterology-Urology Biopsy Instrument
DEVICE DESCRIPTION IV.
The AMS Foreign Body Extractor is made of stainless steel and consists of an obturator, sheath, grasper, seals, handle, security clip, telescope stabilizers and ACMI adaptor ring. The AMS Foreign Body Extractor Accessory Kit contains replacement security clip, telescope stabilizers, ACMI adaptor ring, and seals. To facilitate insertion into the urethra and bladder, the obturator is placed inside the sheath. Once inside the bladder, the obturator is removed and the grasper is placed within the lumen of the sheath. The handle is then attached and the telescope inserted into the sheath. The grasping jaws are operated by moving the handle to open and close the grasping jaws to capture and remove the foreign body.
V. INDICATION FOR USE
The AMS Foreign Body Extractor is intended for use in the removal of a foreign body from the bladder under direct vision.
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COMPARISON TO PREDICATE DEVICE VI.
The AMS Foreign Body Extractor is substantially equivalent to the Richard Wolf 8393 Modular Biopsy Forceps and the Richard Wolf series 8962 Rigid Forceps with Alligator Jaws which are in commercial distribution.
a. Intended Use
The AMS Foreign Body Extractor is intended to remove a foreign body from the bladder under direct vision. The Richard Wolf 8393 series modular biopsy forceps are used for removal of tissue for biopsy. The Richard Wolf Rigid Forceps with alligator jaws are intended for the percutaneous removal of kidney stones.
Principles of Operation b.
The AMS Foreign Body Extractor utilizes a grasper operated by handle grips to grasp foreign bodies, retract within a sheath and subsequently remove from the bladder. The Richard Wolf series 8393 modular forceps similarly utilize a grasper which is operated by handle grips to transurethrally grasp and subsequently remove material. The Richard Wolf 8962 Rigid forceps with alligator jaws utilize a similar grasper which is manipulated by handle grips to grasp and remove stones from the kidneys.
Device Performance C.
The AMS Foreign Body Extractor is manufactured primarily from stainless steel, which is widely used in the medical device industry. The material has previously undergone biocompatibility testing.
All components are verified to ensure that only those meeting all parameters are released for sale.
The Richard Wolf series 8393 modular forceps and the Richard Wolf rigid forceps with alligator jaws both utilize stainless steel in the functional components of the tools.
d. Bench Testing
American Medical Systems has provided descriptive data on the test plan and test results for the Foreign Body Extractor. These data support that the function and characteristics of the device are suitable for its intended use.
In summary, American Medical Systems has provided information within the 510(k) Premarket Notification to indicate that the Foreign Body Extractor is safe and effective for its intended use in the removal of foreign bodies from the bladder. Additionally, the Foreign Body Extractor has been shown to be comparable in terms of intended use and technological characteristics to biopsy forceps currently in commercial distribution.
S/12011 P2 . F2
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health and Human Services. The logo features a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 9 1997
AMS Foreign Body Extractor
Received: August 22, 1997
21 CFR §876.4680/Product code: 78 FFFL
Dated: August 21, 1997
Regulatory class: II
Ms. Ginger Sackett Glaser Regulatory Affairs Specialist American Medical Systems, Inc. Pfizer Hospital Products Group 10700 Bren Road West Minnetonka, Minnesota 55343
Dear Ms. Glaser:
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 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). You may, therefore, 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.
Re: K972091
If your device is classified (see above) into either class II (Special Controls) or class III (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 (QS) 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 vours.
htillian 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
Enclosure
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510(k) Number (if Known):
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The AMS Foreign Body Extractor is intended for use in the removal of a foreign body from the bladder under direct vision.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Rittinger/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 97209 510(k) Number
Prescription Use
(Per 21 CFR 801.109) ✓
Over the Counter Use_
§ 876.4680 Ureteral stone dislodger.
(a)
Identification. A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.