(250 days)
The Endometrial Sampling Syringe can be used for a variety of clinical conditions which could include the following:
- For histological biopsy of the endometrium & endo-cervix in post menopausal screening. .
- Hormone therapy monitoring. .
- Endometrial dating .
- Detection of endometrial carcinoma .
- Bacterial culturing .
This device is being designed to allow the safe and effective the histologic biopsy of the endomethum "and" endometrial carcinoma, endometrial dating and bacterial culturing. This is achieved by a design where the slim form of the sampling syringe makes in most This is actieved by a dealer which as a polypropylene sheath permitting easy entry into the uterine cavity. The sheath / cannula mechanism gives good suction and when combined with the shape and form of the curette opening gives good sample extraction.
The provided document set describes the Rocket Medical plc Endometrial Sampling Syringe, which was submitted for 510(k) clearance. This means the device demonstrated substantial equivalence to a predicate device already on the market, rather than proving its safety and effectiveness through extensive clinical trials for de novo approval. Therefore, the information requested regarding acceptance criteria, specific study designs, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies is largely inapplicable or not detailed in this specific submission.
Here's an attempt to answer the questions based on the provided text, highlighting where information is not available due to the nature of a 510(k) submission focused on substantial equivalence:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, the "acceptance criteria" are typically related to demonstrating equivalence in design, materials, and intended use to a predicate device. "Reported device performance" in this context refers to the comparison against the predicate, primarily on physical characteristics.
| Acceptance Criteria (Implied for 510(k) Equivalence) | Reported Device Performance (Rocket Endometrial Sampling Syringe compared to Unimar Endometrial Pipelle) |
|---|---|
| Design and Dimensional Equivalence: | |
| Outer Sheath Overall Length | 26mm |
| Outer Sheath Outer Diameter | 3.1 od |
| Outer Sheath Inner Diameter | -- (Not directly comparable) |
| Outer Sheath Graduations | 6-14cm |
| Sampling Hole Size | 2mm |
| Sampling Hole Bevel Angle | Perpendicular punch |
| Sampling Hole Location | 5mm from distal end |
| Inner Piston Initial Position | 233mm |
| Material Equivalence: | (Implied as comparable, but not explicitly stated materials) |
| Intended Use Equivalence: | Matches Indications for Use of predicate device |
| Functional Equivalence (implied for biopsy efficacy): | "Gives good suction and when combined with the shape and form of the curette opening gives good sample extraction." |
| Flexural Properties: | "comparable with the Unimar Endometrial Pipelle" |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. The submission states, "The device has yet to be clinically evaluated but has been subjected to a real laboratory performance testing against competitor product." This indicates in vitro or bench testing, not human subject testing with a "test set" in the sense of clinical data. There is no information on the number of samples used in this laboratory testing.
- Data Provenance: The device is manufactured by Rocket Medical plc in Tyne & Wear, England. The laboratory performance testing would have been conducted internally or by a contracted lab. The data is likely non-clinical/bench test data, not patient data.
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. As described, no clinical "test set" with human subjects requiring expert ground truth establishment was used for this 510(k) submission. The evaluation was laboratory-based comparison to a predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical "test set" with human subjects requiring adjudication was used.
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 an endometrial sampling syringe, not an AI-assisted diagnostic tool or a device that impacts human reader performance. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (syringe), not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. For the in vitro or bench testing, the "ground truth" would be the measurable physical and functional specifications of the predicate device, against which the new device was compared. For example, comparing the actual sampling hole size of the Rocket syringe to the stated size of the Unimar Pipelle. There's no pathological, outcomes, or expert consensus ground truth mentioned for this type of submission.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/ML device.
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Rocket Medical plc - 510(k) Notification Endometrial Sampling Syringe
Summary of Safety and Effectiveness
JE: 5 = 2004
eplaced
S2
K040189
Page 1 of 2
Common or usual name: Classification name:
Endometrial Sampling Syringe Endometrial Suction Curette & Accessories CFR# 884.1175 Class II
This device is being designed to allow the safe and effective the histologic biopsy of the This device is being designed to ancyost menopausal screening and hormone therapy endomethum "and" endometrial carcinoma, endometrial dating and bacterial culturing.
This is achieved by a design where the slim form of the sampling syringe makes in most This is actieved by a dealer which as a polypropylene sheath permitting easy entry into the uterine cavity.
The sheath / cannula mechanism gives good suction and when combined with the shape and form of the curette opening gives good sample extraction.
This is a class II device, registered by Rocket Medical (Establishment number: 8010022/9610632). This device is substantially equivalent to a medical device which is 8010022. For 0032). "This been submitted to the FDA, marketed by Unimar Inc, 475 Currently in commore and has over on only of the name: Endometrial Pipelle.
The device we believe is safe and effective for the application for which it is intended having The device we believe is baie anwaluation. The device has yet to be clinically evaluated but been subjected to a real laboratory performance testing against competitor product.
Rocket Medical will continue to searcy all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety sancey and effectiveness information and as such, applicable data will be recorded for this product.
CERTIFICATION
I hereby certify that this Summary of Safety and Effectiveness applies for the above indicated device.
| 15. 5. 2004 | T. Charlton |
|---|---|
| Date | Signed by Tracy Charlton |
| Regulatory Affairs Manager | |
| Rocket Medical plc | |
| Wear Industrial Estate, Washington | |
| Tyne & Wear, England. NE38 9BZ | |
| Contact Person/Submitter | Mr Richard Keen |
| Compliance Consultants | |
| 1151 Hope Street, Stamford, Connecticut 06907, USA | |
| Tel: 001 203 329 2700 Fax: 001 203 329 2345 |
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| ubstantial Equivalence | ||
|---|---|---|
| Rocket Endometrial Sampling Syringe | Unimar Endometrial Pipelle | |
| Outer Sheath | Overall Length 26mmOuter diameter 3.1 odInner diameter --Graduations 6-14cm | 265mm3.1 od2.6 id4-10cm |
| Sampling Hole | Size 2mmBevel angle Perpendicular punchLocation 5mm from distal end | 2.4mmPerpendicular punch8mm from distal end |
| Inner Piston (Cannula) | Initial position relative tosampling hole 233mm 225mm | |
| Assembled device | Flexural properties Rocket Medical's Endometrial Sampling Syringe is comparible with the Unimar EndometrialPipelle in dimensional sizes, look and material as per the above dimensions etc. We believe this isproof with regard to the flexural properties and also likeness of a similar product on the currentUS market. | |
| Equivalent to: Unimar Inc, 475 Danbury Road, Wilton, CT 06897, 510(k) Number K854415.Device name: Endometrial Pipelle. |
Question 6
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Appendix A
updated
in A1
K040189
page 2 of 2
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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 with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is facing to the right. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 4 - 2004
Rocket Medical PLC ්% Mr. Richard Keen Compliance Consultants 1151 Hope Street STAMFORD CT 06907 Re: K040189 Trade/Device Name: Embryon® Endometrial Sampling Syringe Regulation Number: 21 CFR 884.1175 Regulation Name: Endometrial suction curette and accessories
Regulatory Class: II Product Code: 85 HHK Dated: July 16, 2004 Received: July 26, 2004
Dear Mr. Keen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have revewed your Section 710(ts) prematically equivalent (for the indications for use stated in above and have decemined the de nee icate devices marketed in interstate commerce prior to the enclosure) to regally mankeled predical Device Amendments, or to devices that have been May 26, 1970, the elacinent date of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordatics with the provisions of application (PMA). You may, therefore, market the do not require approval of a premance approvisions of the Act. The general controls provisions of the Act. device, subject to the general controls providenties, 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 classified (see ao ro) miss and controls. Existing major regulations affecting your Apploval), it may oc subject to sactrademons, 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 Please be advised mat 1 D/P 3 155dailed of acvice complies with other requirements of the Act of any FDA has made a decemination mad your active rederal agencies. You must comply with all the Federal statues and regulations administered of only - entitle - end 807); labeling Act s requirements, metuding, but not minted to regulations as set forth in the quality systems (QS) (21 CFR Part 801); 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) This letter will anow you to begin manceing your ence of your device of your device to a legally premarket nothcation. The I DA Inding of backannal report 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 Pat 801), please If you desire specific advice for your device of our 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, prease note the regulation enation on your responsibilities under the Act from the 807.97). Tou may outlin other general mistiance and Consumer Assistance at its toll-free number (800) DWNslon of 301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmadsmam.html
Singerely 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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Indications for Use
510(k) Number (if known): K040189
Embryon® Endometrial Sampling Syringe Device Name:
Indications for Use:
The Endometrial Sampling Syringe can be used for a variety of clinical conditions which could include the following:
- For histological biopsy of the endometrium & endo-cervix in post menopausal screening. .
- Hormone therapy monitoring. .
- Endometrial dating .
- Detection of endometrial carcinoma .
- Bacterial culturing .
Prescription Use (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
David A. Logman
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Dev 510(k) Number
§ 884.1175 Endometrial suction curette and accessories.
(a)
Identification. An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps.(b)
Classification. Class II (performance standards).