(180 days)
No
The description focuses on mechanical and electrical components for tissue acquisition and cautery, with no mention of AI/ML terms or functionalities.
Yes.
The device performs procedures such as tissue sample acquisition, controlled coagulation/cautery, and sessile polyp removal, all of which are considered therapeutic interventions in the gastrointestinal tract.
No
The device is used for tissue sample acquisition, coagulation/cautery, and polyp removal, which are interventional or therapeutic procedures, not diagnostic ones.
No
The device description clearly outlines physical components like a handle, electrosurgical plug, coil/spring/rod mechanism, biopsy cup/alligator forceps, and a sheath of electrical insulation. This indicates a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The description clearly states the device is used for "endoscopic tissue sample acquisition, controlled coagulation/cautery, and sessile polyp removal in the gastrointestinal tract." This is a device used within the body for surgical and tissue collection procedures.
- Lack of Testing: The description focuses on the physical characteristics of the device and its function in collecting tissue and performing cautery. There is no mention of using the collected tissue for in vitro testing or analysis.
The device is a surgical instrument used for procedures within the gastrointestinal tract, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
The reprocessed hot biopsy forceps are intended to be used for endoscopic tissue sample acquisition, controlled coagulation/cautery, and sessile polyp removal in the gastrointestinal tract.
Product codes
NLU
Device Description
The device consists of a proximal handle containing an electrosurgical plug which is connected, via a coil, spring or rod mechanism, to the biopsy cup or alligator forceps at the distal tip. The biopsy forceps range from 160 to 240 cm in length and 2.2-2.5 mm in diameter. The jaws range from 2.2 to 2.5 mm in diameter. The cup forceps may or may not have serrated edges, a fenestration, needle, or distal biting tooth. The forceps are covered with a sheath of electrical insulation. The electrosurgical plug on the handle used for connection to the appropriate electrosurgical unit. This submission does not include the electrosurgical box that the forceps connect to or its associated connecting cable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Gastrointestinal tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Representative samples of reprocessed hot biopsy forceps underwent bench testing to demonstrate appropriate functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
"Thermal Option" Hot Biopsy Forceps (K932790), "The Shark" Hot Biopsy Forceps (K923470), "Radial Jaw" Hot Biopsy Forceps (K860366), "Precisor" Hot Biopsy Forceps (K905088)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
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JUL 2 0 2005
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SUMMARY AND CERTIFICATION SECTION 2.
2.A. 510(K) SUMMARY
.
| Submitter: | SterilMed, Inc. |
|---|---|
| Contact Person: | Dr. Bruce R. Lester |
| SterilMed, Inc. | |
| 11400 73rd Avenue North | |
| Minneapolis, MN 55369 | |
| Ph: 763-488-3400 | |
| Fax: 763-488-3350 | |
| Date Prepared: | January 19, 2005 |
| Trade Name: | Reprocessed Hot Biopsy Forceps |
| Classification Name: | |
| and Number: | Electric Biopsy Forceps |
| Class II, 21 CFR 876.4300 | |
| Product Code: | NLU |
| Predicate Device(s): | The reprocessed hot biopsy forceps are substantially |
| equivalent to: "Thermal Option" Hot Biopsy Forceps | |
| (K932790), manufactured by Ballard (formerly Cox); "The | |
| Shark" Hot Biopsy Forceps manufactured by Wilson-Cook | |
| (K923470); "Radial Jaw" Hot Biopsy Forceps (K860366), | |
| manufactured by Microvasive; and "Precisor" Hot Biopsy | |
| Forceps (K905088), manufactured by Bard (formerly | |
| ESCO). | |
| Device Description: | The device consists of a proximal handle containing an |
| electrosurgical plug which is connected, via a coil, spring | |
| or rod mechanism, to the biopsy cup or alligator forceps at | |
| the distal tip. The biopsy forceps range from 160 to 240 | |
| cm in length and 2.2-2.5 mm in diameter. The jaws range | |
| from 2.2 to 2.5 mm in diameter. The cup forceps may or | |
| may not have serrated edges, a fenestration, needle, or | |
| distal biting tooth. | |
| The forceps are covered with a sheath of electrical | |
| insulation. The electrosurgical plug on the handle used for | |
| connection to the appropriate electrosurgical unit. This | |
| submission does not include the electrosurgical box that the | |
| forceps connect to or its associated connecting cable. | |
| Intended Use: | The reprocessed hot biopsy forceps are intended to be used |
| for endoscopic tissue sample acquisition, controlled | |
| coagulation/cautery, and sessile polyp removal in the | |
| gastrointestinal tract. | |
| Functional and | |
| Safety Testing: | Representative samples of reprocessed hot biopsy forceps |
| underwent bench testing to demonstrate appropriate | |
| functional characteristics. Process validation testing was | |
| done to validate the cleaning and sterilization procedures as | |
| well as the device's packaging. In addition, the | |
| manufacturing process includes visual and functional | |
| testing of all products produced. | |
| Conclusion: | The hot biopsy forceps reprocessed by SterilMed are |
| substantially equivalent to the following specific predicate | |
| devices: "Thermal Option" Hot Biopsy Forceps (K932790), | |
| manufactured by Ballard (formerly Cox); "The Shark" Hot | |
| Biopsy Forceps manufactured by Wilson-Cook (K923470); | |
| "Radial Jaw" Hot Biopsy Forceps (K860366), | |
| manufactured by Microvasive; and "Precisor" Hot Biopsy | |
| Forceps (K905088), manufactured by Bard (formerly | |
| ESCO). This conclusion is based upon the devices' | |
| similarities in functional design, materials, indications for | |
| use and methods of construction. |
1
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JUL 2 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bruce R. Lester, Ph.D. Vice President of R&D SterilMed, Inc. 11400 73rd Avenue North MAPLE GROVE MN 55369
Re: K050136
Trade/Device Name: SterilMed Reprocessed Hot Biopsy Forceps (see enclosure) Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: NLU Dated: April 27, 2005 Received: April 28, 2005
Dear Dr. Lester:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have route determined the device is substantially equivalent (for the indications for use stated in above and have as a legally marketed predicate devices marketed in interstate commerce prior to the cholors, the enactment date of the Medical Device Amendments, or to devices that have been May 20, 1710, and classified in accordans of the Federal Food, Drug, and Cosmetic Act (Act) that tecassinod in accordatios approval application (PMA). You may, therefore, market the do not require approvations of the Act. The general controls provisions of the Act. device, subjoc to 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 (Premarket If your device is older to such additional controls. Existing major regulations affecting your Approval), a the you be boor 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 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 I caral statues and rogalding, 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) (2) CFR Part 807); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter with anow you to ogin manenes of your device of your device to a legally premarked nothleation: "The PDF mailig sification 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 specific auvice tor your acrees on 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 Also, please note the regulation entitled, " have the on your responsibilities under the Act from the 807.97). Tou Inay Outain other general 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/cdrh/industry/support/index.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
4
Attachment - Reprocessed Hot Biopsy Forceps (K050136)
| Bard |
|---|
| 000852 |
| 000853 |
| 000854 |
| 000856 |
| Ballard |
| 60101 |
| 60102 |
| 60103 |
| 60104 |
| 60107 |
| 60108 |
| 60109 |
| 60110 |
| 60113 |
| 60114 |
| 60115 |
| 60116 |
| 60119 |
| 60120 |
| 60121 |
| 60122 |
| Microvasive |
1 250
Wilson-Cook
HS-2.5-230 HDS-2.5-230
'문관 1
:
.
5
Indications for Use
| 510(k) Number (if known): | K050136 |
|---|---|
| Device Name: | Reprocessed Hot Biopsy Forceps |
| Indications For Use: |
The Reprocessed Hot Biopsy Forceps are intended to be used for endoscopic tissue sample acquisition, controlled coagulation/cautery, and sessile polyp removal in the gastrointestinal tract.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Darrey C. hagdon
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 0501-510(k) Number _