(90 days)
No
The device description and intended use describe a physical, reusable surgical instrument with no mention of software, data processing, or AI/ML terms.
No
The device is described as an instrument used in a surgical procedure (circumcision) to compress the foreskin, not to treat or cure a disease or condition. It's a surgical tool, not a therapeutic device in the sense of delivering therapy.
No
Explanation: A Circumcision Clamp is an instrument used in a surgical procedure to compress the foreskin; it does not diagnose any condition.
No
The device description explicitly states it is a stainless steel, reusable, and "mogenstyle" circumcision clamp, which is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body (like blood, urine, tissue) to provide information about a person's health.
- This device is a surgical instrument used directly on the human body during a procedure. It is a clamp used to compress the foreskin.
The description clearly states its use in a surgical procedure on the penis, not for testing biological samples.
N/A
Intended Use / Indications for Use
The TS Medical Circumcision Clamp is intended to be used in a medical The TO Modical Sirvament of the penis during circumcision of a male infant.
A Circumcision Clamp is an instrument used in a procedure to compress the foreskin of the penis during circumcision of a male infant or child
Product codes
HFX, 85 HFX
Device Description
The TS Medical Circumcision Clamp is a stainless steel, reusable, and "mogenstyle" circumcision clamp. The T.S. Medical Circumcision Clamps are constructed of stainless steel that meets the requirements of ASTM-F 899, Stainless Steel Bullet. Bar and Wire for Surgical Instruments.
The following size will be offered: 2.5 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penis
Indicated Patient Age Range
male infant or child
Intended User / Care Setting
medical
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)
Non-clinical tests were not performed.
Clinical tests were not performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K935491, Mogen Circumcision Instruments, Ltd. (grand fathered)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. 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 § 884.9.
0
Attachment 1
page 1 of 2
JAN 2 2 2004
510(K) SUMMARY
This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 5l0(k) number is: Ko33 403
Submitter's Identification: 1.
T.S.Medical 208 Carter Drive, Suite 12A West Chester, Pa 19382 USA
Date Summary Prepared: October 23, 2003
2. Name of the Device:
- Proprietary: T.S. Medical Circumcision Clamp a.
- Common Name: Mogen Style Circumcision Clamp b.
- Classification Name: Circumcision Clamp C.
- Device Class: 21 CFR 884.4530, Class II d.
- Classification Panel: Obstetrical and Gynecological Panel e.
- Product Code: HFX f.
Predicate Device Information: 3.
The TS Medical Circumcision Clamp is identical in materials, design, and intended use to the circumcision clamps marketed by Tri-State Medical Corp. (K935491) and the Mogen Circumcision Clamp marketed by Mogen Circumcision Instruments, Ltd. (grand fathered). Each of these clamps is in the "mogen- style" and is constructed of medical stainless steel. All are intended for infant circumcision and are reusable.
4. Device Description:
The TS Medical Circumcision Clamp is a stainless steel, reusable, and "mogenstyle" circumcision clamp. The T.S. Medical Circumcision Clamps are constructed of stainless steel that meets the requirements of ASTM-F 899, Stainless Steel Bullet. Bar and Wire for Surgical Instruments.
The following size will be offered: 2.5 mm.
1
K033403
Page 2 of 2
5. Intended Use:
The TS Medical Circumcision Clamp is intended to be used in a medical The TO Modical Sirvament of the penis during circumcision of a male infant.
Comparison to Predicate Devices: 6.
The TS Medical Circumcision Clamp to substantially equivalent in materials, design, and intended use to the predicate devices.
Discussion of Non-Clinical Tests Performed: 7.
Non-clinical tests were not performed.
Discussion of Clinical Tests Performed: 8.
Clinical tests were not performed.
9. Conclusions:
The TS Medical Circumcision Clamp is safe and effective for it's intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2004
T.S. Medical, Inc. % Ms. Carolann Kotula Official Correspondent mdi Consultants, Inc. 55 Northern Blvd., Suite 200 GREAT NECK NY 11021
Re: K033403 Trade/Device Name: T.S. Medical Circumcision Clamp Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: 85 HFX Dated: October 23, 2003 Received: October 24, 2003
Dear Ms. Kotula:
We have reviewed your Scction 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications 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 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 (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.
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.
3
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 the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brydon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
4
Attachment 4
Indications for Use
510(k) Number (if known): K033403
Device Name: T.S. Medical Circumcision Clamp
Indications For Use: A Circumcision Clamp is an instrument used in a procedure to compress the foreskin of the penis during circumcision of male infant or child
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)
Page 1 of 1
David b. Lenman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device
510(k) Number K033403